SAGES

Reimagining surgical care for a healthier world

SAGES Response to NordICC Study Regarding Benefit of Screening Colonoscopies

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The NordICC Study recently published in The New England Journal of Medicine and widely reported on by media outlets has raised questions regarding the benefit of screening colonoscopy in lowering the risk of colorectal cancer and cancer-related deaths among otherwise healthy and symptom-free men and women aged 55 to 64.

Provocative headlines and commentaries have added further to the controversy, with one outlet (CNN) describing colonoscopies as the “dreaded rite of passage for many middle-aged adults. The promise has been that if you endure the awkwardness and invasiveness of having a camera travel the length of your large intestine once every decade after age 45, you have the best chance of catching – and perhaps preventing – colorectal cancer.”

SAGES hopes to clarify the results of the NordICC study and frame them in the context of decade-long efforts by several national agencies to reduce the risk of colorectal cancer, the second leading cause of cancer death in the United States, by promoting early detection and treatment of lesions. The NordICC study enrolled 84,585 patients across Poland, Norway, and Sweden where patients were randomized to either receive a screening invitation (to undergo colonoscopy) or to follow usual care. At a median follow-up of 10 years, the authors found that the risk of developing colorectal cancer was 18% lower in the group invited to undergo screening and the risk of death from colorectal cancer was not significantly lower relative to the usual care group (0.31% vs 0.28%). These results deviate from the results of prior screening trials and fell short of the expected 25% reduction in colorectal cancer-related mortality.

However, these results must be interpreted with caution considering the significant design limitations. Among patients who received an invitation to undergo screening, only 42% complied with the study protocol and underwent colonoscopy. Despite the lower-than-expected compliance with the screening protocol, all patients in the screening arm, including the 58% of patients who did not undergo colonoscopy, were still included in the “invited to undergo screening” group, which significantly diluted the impact of screening colonoscopy on reducing colorectal cancer incidence and cancer-related mortality. In addition, the study did not specify when or how the patients who did not undergo screening colonoscopy underwent subsequent diagnosis of colorectal cancer. Given that there were no significant differences in cancer stage at diagnosis between the groups, colonoscopy presumably played a role in establishing a diagnosis in both groups and impacted cancer-related mortality across the entire cohort of patients.

Ultimately, the most important finding of the NordICC study is that a screening colonoscopy did reduce the risk of colorectal cancer at 10 years. The lower-than-expected benefits, especially as it relates to reducing cancer-related mortality, should not impact national recommendations regarding colorectal cancer screening. At this time, colonoscopy remains the most effective screening test to identify and reduce the incidence of colorectal cancer. Guidelines for screening have been established by the American Cancer Society to begin at age 45 for patients with average risk. Patients with other risk factors such as family history may benefit from earlier screening. Colonoscopy for screening in average risk patients was approved by CMS for Medicare beneficiaries in 2000 and is almost universally covered by most private insurance carriers.

SAGES affirms the value of colonoscopy in the prevention, identification, and treatment of colorectal cancer based on the preponderance of evidence. We urge the public to follow the guidelines for screening to prevent colon cancer. We also advocate for the insurance industry to maintain coverage for screening colonoscopy to ensure equitable access to care and maintain the standard for public health. SAGES represents more than 6,000 surgeons and endoscopists who care for patients with GI diseases including colon cancer. Our members are focused on the use of flexible endoscopy and minimally invasive surgery techniques to achieve the best results for our patients.

Name

SAGES Recommendations Regarding Surgical Management of Gastric Cancer Patients During the Response to the COVID-19 Crisis

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Note: these recommendations are subject to change and update.

Introduction

The care for all patients with cancer requires multidisciplinary review and decision-making, and entails the consideration of many factors in order to develop a sound plan of treatment. This requires a detailed assessment of patient, disease, surgical team, and hospital resources. (1) These principles remain critical and in fact, arguably more important now as we combat the COVID-19 pandemic than ever before. Thus a “one size fits all” recommendation would be unwise due to significant variability in patient presentation, individual comorbidities, disease severity, regional pandemic burden, and hospital-regional resources. It is important to recognize this document presents general recommendations. These are meant to be helpful to the surgeon while recognizing that the individual surgeon and patient will need to decide upon the course of therapy depending on local resources and individual situations.

The recommendations below are aimed to help guide practicing surgeons by providing a framework to address more urgent cancer cases, and to help stratify options that may diminish risk and improve outcomes. To address these concerns, we refer to several resources including the Elective Surgery Acuity Scale (ESAS) (2) as published by the American College of Surgeons (ACS).

As each surgeon assesses their patient, it should be kept in mind that at of the date of this publication, no region in the USA is thought to have peaked in this epidemic. Thus, conditions are expected to get worse before improving. Having said that, when areas experience a “flattening of the curve”, some non-emergent surgeries may be considered.

ESSENTIAL POINTS TO HELP WITH CANCER CARE TRIAGE

Important Considerations for all Cancer Patients:

  1. The comorbidities and age of the patient are paramount in assessing the relative risk and benefit of exposing the patient to coronavirus versus pursuing alternative, next-best options such as neoadjuvant chemotherapy prior to operation.
  2. The resources available to the surgeon and hospital at the time of assessment are also critical. Since this pandemic is dynamic in terms of patient acuity, volume, and hospital resources, the current state and immediate potential future state of the hospital system at the time of the proposed operation and anticipated postoperative inpatient recovery needs to be considered.

COVID-19 PHASE of Hospital or Healthcare System:
Phase Condition Description
0 Unaffected No COVID-19 patients, hospital operating as normal
I Semi-urgent COVID-19 patients are in the hospital, but resources and ICU beds/ventilators are not threatened
II Urgent Many COVID-19 patients are in the hospital, ICU beds/ventilator availability is strained and operative and/or PPE resources are limited
III Emergent Crisis situation where most ICU/ventilator resources are directed to COVID-19 patients and operating room and/or PPE equipment are minimally or entirely unavailable
  1. The urgency of the operation proposed. Most hospital systems are endorsing that, as hospital resources allow, patients with cancer should undergo curative resection if delaying surgery by more than 3 months will adversely impact tumor and oncologic outcomes.
  2. Testing for coronavirus prior to operation is strongly encouraged, contingent on testing availability. This is encouraged as a precaution for your patients who may be about to become ill, as well as for staff and the surgical provider, who need to be stewarded as fundamental workforce resources for our patients. A complex surgical procedure will likely affect a patient’s immune system, and deferral should be considered for COVID-positive patients until the COVID disease process has stabilized.
  3. Open surgery and minimally invasive approaches – Consideration should be given when performing open, laparoscopic or robotic surgical approaches to risks of aerosolization of the virus. As long as the patient is negative for the virus either approach is appropriate. However, for patients who are positive for the virus and require more urgent operation, each approach has its own considerations. Concerns exist regarding potential viral contamination with pneumoperitoneum during laparoscopic and robotic surgery. Even though there is no clear evidence it occurs with COVID-19, the risk cannot be overlooked and there are ways of mitigating the risk as we previously described (see link below). During open surgery, the risk of viral spread within the plumes generated by electrosurgery or other energy sources is also to be considered. Robotic approaches in confirmed or suspected COVID-19 patients also had the added consideration of potential contamination of the robotic equipment. https://www.sages.org/resources-smoke-gas-evacuation-during-open-laparoscopic-endoscopic-procedures/; https://www.sages.org/recommendations-surgical-response-covid-19/
  4. Likelihood for need of ICU – Patients who are expected to require significant time in the hospital, or have a higher risk of peri-operative complications potentially requiring ICU or step-down unit/telemetry services that may be needed for acutely ill COVID patients, should be have their operation timed to avoid surge resource constraints and contamination, if possible.
  5. Length of time for recovery – The benefits of MIS surgery with reduced hospital stay and higher rate of discharge to home, rather than a nursing home, should be considered in planning surgical approaches. (3, 4)
  6. Consenting the patient for surgery – The potential risks and implications of doing surgery during the COVID-19 pandemic, particular to the local institution, should be clearly discussed with the patient and family when obtaining consent for surgery.

General management strategies for patients with cancer during COVID-19 pandemic (Tier-based):

Generally, cancer patients require resources and support services that are typically stressed during pandemics. Further, early reports in this pandemic show that viral infection with COVID-19 tends to be specifically more lethal in cancer patients (5). This highlights that surgeons and systems must recognize that all cancer patients are in a high-risk category.

Tier 1a Tier 1b Tier 2a Tier 2b Tier 3a Tier 3b
Low acuity surgery/healthy patient

Outpatient surgery

Not life- threatening illness

 Low acuity surgery/unhealthy patient Intermediate acuity surgery/healthy patient

Not life threatening but potential for future morbidity and mortality.

Requires in hospital stay

 Intermediate acuity surgery/unhealthy patient High acuity surgery/healthy patient High acuity surgery/unhealthy patient

Modified from COVID-19: Guidance for Triage of Non-Emergent Surgical Procedures. American College of Surgeons, Clinical Issues and Guidance (2)

General comments on cancer patients as they relate to the ESAS tier system:

  • Tier 3a or 3b (ESAS): All patients in this Tier should undergo appropriate procedures to remedy their urgent or emergent condition.**
  • Tier 2a or 2b (ESAS): The majority of cancer patients will fall in Tier 2. The guiding principle here is that these patients will require multidisciplinary input (done virtually as needed), and also that the surgeon carefully assess all variables listed above . Patients falling in the high-risk category, i.e. personal high-risk features or high-risk due to environment and resource issues (as outlined by the considerations above ), should preferentially be offered non-operative alternative measures in-lieu of surgery . If surgery cannot be avoided, measures to reduce inpatient LOS are recommended.***
  • Tier 1a or 1b (ESAS): All patients in this Tier are considered elective and should be delayed until pandemic is stabilized, resources are rebalanced, and risk is returning to baseline levels.

**When multiple options exist, especially for Tier 3b, the surgeon is encouraged to choose the treatment option that minimizes use of resources and decreases risk to patient and healthcare. (1)

***Disease site specific non-operative alternative measures are outlined below.

Site Specific Recommendations:

III. Management strategies for patients with gastric cancers during COVID-19 pandemic:

For patients presenting with new gastric cancers at this time, we propose specific recommendations and guidelines to consider when deciding whether to proceed or delay an operation for these patients. In the following case scenarios, we are adhering to the 3 month-rule (is the cancer likely to progress in the next three months without treatment?)

  1. Stage of gastric cancer – For the specific stages below, surgeons need to consider the hospital COVID-19 phase response (above ). For Phase I, consider non-surgical alternatives, however, surgery may be acceptable. For COVID-19 Phase II – III, surgery would be delayed until the pandemic abates and resources return.
    1. For patients with stage-specific gastric cancer
      1. T1a cancers – these patients may be candidates for EMR or ESD and referring them for a same-day procedure. These may be considered in Phase I depending on hospital resources. If not, then weekly “check-ins” to reassess the stage are reasonable to find the best “window”. In Phase II – III, these should be deferred. Also note, there are concerns for aerosolization with endoscopic procedures (EMR/ESD) and thus we recommend delaying these procedures and ensuring patient is COVID-19 negative.
      2. T1b and T2 cancers – these patients need surgery, however, a 4 – 6 week window to time the operation when hospital resources are optimal (relatively-speaking) is reasonable. Minimally invasive options are preferable as they will likely decrease the length of stay in the hospital.
      3. T3 or higher cancers, or those who are clinically node positive – these are patients in whom neoadjuvant chemotherapy is recommended, allowing physicians a 3-4 month window to plan surgery (likely after the crisis phase has passed). Staging Diagnostic Laparoscopy – although patients with this stage of gastric cancer typically have staging with diagnostic laparoscopy prior to initiation of chemotherapy to rule out occult metastatic disease, if hospital resources and space is critical at the time and the patient is at higher risk due to age or comorbidities, then consideration for proceeding straight to chemotherapy is reasonable. Plan for diagnostic laparoscopy after chemotherapy is completed and prior to operation.
      4. Obstructing and Bleeding Gastric Cancers – for gastroesophageal junction cancers, immediate initiation of chemotherapy and radiation therapy may obviate the need for a stent for gastric outlet obstructions. If the obstruction is complete and the patient requires admission to a hospital, then proceed with gastrectomy. However, for near-complete obstructions, chemotherapy may improve the ability to eat within 2-3 days. Avoid stents as they make as they could make subsequent procedures more challenging.
      5. For a bleeding lesion, non-surgical approaches (IR and or endoscoy) should be attempted first. When not able to control otherwise, a surgical resection may be indicated.
      6. Patients who have completed Neoadjuvant treatment and are Waiting for Surgery – these patients are difficult to manage, although from last chemotherapy to operation there is a window of 3-6 weeks during which surgery can be planned without losing the opportunity for potential cure. For some patients, consider speaking with the medical oncologist about adding an additional 1-2 cycles of chemotherapy to bridge the patient through the worst of the pandemic crisis and plan surgery thereafter.

General Comment

Optimally managing cancer patients within the confines of limited medical resources is a hurdle rarely encountered in modern times in the USA. Never before has our Hippocratic Oath come more into play. This document will be updated as new scenarios or suggestions are posted. Again, it is of paramount importance to recognize these as general recommendations are meant to be helpful to the surgeon, while recognizing that the individual surgeon and patient will need to decide upon the course of therapy depending upon local resources and individual situations.

We will all make difficult decisions and all stand behind one another, as we should always strive to do. Prioritizing the patient’s needs and wishes, the family, and standing by them in the surgeon-patient relationship whatever course is necessitated, remains our professional calling and commitment.

References

  1. Kutikov A, Weinberg DS, Edelman MJ, et al. A War on Two Fronts: Cancer Care in the Time of COVID-19. Ann Intern Med. 2020; [Epub ahead of print 27 March 2020]. doi: https://doi.org/10.7326/M20-1133
  2. COVID-19: Guidance for Triage of Non-Emergent Surgical Procedures. American College of Surgeons, Clinical Issues and Guidance. https://www.facs.org/covid-19/clinical-guidance/triage online March 17 2020 and accessed Apr 1st 2020.
  3. Delaney CP, Chang E, Senagore AJ, et al. Clinical Outcomes and Resource Utilization Associated with Laparoscopic and Open Colectomy Using a Large National Database. Ann Surg. 2008; 247: 819 – 824.
  4. Gerber MH, Delitto D, Crippen CJ, et al. Analysis of the Cost Effectiveness of Laparoscopic Pancreatoduodenectomy. J Gastrointest Surg (2017) 21: 1404 – 1410.
  5. Liang W, Guan W, Chen R, et al. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020;21:335-337. [PMID: 32066541] doi:10.1016/S1470-2045(20)30096-6.

SAGES – AHPBA Recommendations Regarding Surgical Management of HPB Cancer Patients During the Response to the COVID-19 Crisis

by

Note: these recommendations are subject to change and update.

Introduction

The care for all patients with cancer requires multidisciplinary review and decision-making, and entails the consideration of many factors in order to develop a sound plan of treatment. This requires a detailed assessment of patient, disease, surgical team, and hospital resources. (1) These principles remain critical and in fact, arguably more important now as we combat the COVID-19 pandemic than ever before. Thus a “one size fits all” recommendation would be unwise due to significant variability in patient presentation, individual comorbidities, disease severity, regional pandemic burden, and hospital-regional resources. It is important to recognize this document presents general recommendations. These are meant to be helpful to the surgeon while recognizing that the individual surgeon and patient will need to decide upon the course of therapy depending on local resources and individual situations.

The recommendations below are aimed to help guide practicing surgeons by providing a framework to address more urgent cancer cases, and to help stratify options that may diminish risk and improve outcomes. To address these concerns, we refer to several resources including the Elective Surgery Acuity Scale (ESAS) (2) as published by the American College of Surgeons (ACS).

As each surgeon assesses their patient, it should be kept in mind that at of the date of this publication, no region in the USA is thought to have peaked in this epidemic. Thus, conditions are expected to get worse before improving. Having said that, when areas experience a “flattening of the curve”, some non-emergent surgeries may be considered.

ESSENTIAL POINTS TO HELP WITH CANCER CARE TRIAGE

Important Considerations for all Cancer Patients:

  1. The comorbidities and age of the patient are paramount in assessing the relative risk and benefit of exposing the patient to coronavirus versus pursuing alternative, next-best options such as neoadjuvant chemotherapy prior to operation.
  2. The resources available to the surgeon and hospital at the time of assessment are also critical. Since this pandemic is dynamic in terms of patient acuity, volume, and hospital resources, the current state and immediate potential future state of the hospital system at the time of the proposed operation and anticipated postoperative inpatient recovery needs to be considered.
COVID-19 PHASE of Hospital or Healthcare System:
Phase Condition Description
0 Unaffected No COVID-19 patients, hospital operating as normal
I Semi-urgent COVID-19 patients are in the hospital, but resources and ICU beds/ventilators are not threatened
II Urgent Many COVID-19 patients are in the hospital, ICU beds/ventilator availability is strained and operative and/or PPE resources are limited
III Emergent Crisis situation where most ICU/ventilator resources are directed to COVID-19 patients and operating room and/or PPE equipment are minimally or entirely unavailable
  1. The urgency of the operation proposed. Most hospital systems are endorsing that, as hospital resources allow, patients with cancer should undergo curative resection if delaying surgery by more than 3 months will adversely impact tumor and oncologic outcomes.
  2. Testing for coronavirus prior to operation is strongly encouraged, contingent on testing availability. This is encouraged as a precaution for your patients who may be about to become ill, as well as for staff and the surgical provider, who need to be stewarded as fundamental workforce resources for our patients. A complex surgical procedure will likely affect a patient’s immune system, and deferral should be considered for COVID-positive patients until the COVID disease process has stabilized.
  3. Open surgery and minimally invasive approaches – Consideration should be given when performing open, laparoscopic or robotic surgical approaches to risks of aerosolization of the virus. As long as the patient is negative for the virus either approach is appropriate. However, for patients who are positive for the virus and require more urgent operation, each approach has its own considerations. Concerns exist regarding potential viral contamination with pneumoperitoneum during laparoscopic and robotic surgery. Even though there is no clear evidence it occurs with COVID-19, the risk cannot be overlooked and there are ways of mitigating the risk as we previously described (see link below). During open surgery, the risk of viral spread within the plumes generated by electrosurgery or other energy sources is also to be considered. Robotic approaches in confirmed or suspected COVID-19 patients also had the added consideration of potential contamination of the robotic equipment. https://www.sages.org/resources-smoke-gas-evacuation-during-open-laparoscopic-endoscopic-procedures/ https://www.sages.org/recommendations-surgical-response-covid-19/
  4. Likelihood for need of ICU – Patients who are expected to require significant time in the hospital, or have a higher risk of peri-operative complications potentially requiring ICU or step-down unit/telemetry services that may be needed for acutely ill COVID patients, should be have their operation timed to avoid surge resource constraints and contamination, if possible.
  5. Length of time for recovery – The benefits of MIS surgery with reduced hospital stay and higher rate of discharge to home, rather than a nursing home, should be considered in planning surgical approaches. (3, 4)
  6. Consenting the patient for surgery – The potential risks and implications of doing surgery during the COVID-19 pandemic, particular to the local institution, should be clearly discussed with the patient and family when obtaining consent for surgery.

General management strategies for patients with cancer during COVID-19 pandemic (Tier-based):

Generally, cancer patients require resources and support services that are typically stressed during pandemics. Further, early reports in this pandemic show that viral infection with COVID-19 tends to be specifically more lethal in cancer patients (5). This highlights that surgeons and systems must recognize that all cancer patients are in a high-risk category.

Tier 1a Tier 1b Tier 2a Tier 2b Tier 3a Tier 3b
Low acuity surgery/healthy patient

Outpatient surgery

Not life- threatening illness

 Low acuity surgery/unhealthy patient Intermediate acuity surgery/healthy patient

Not life threatening but potential for future morbidity and mortality.

Requires in hospital stay

 Intermediate acuity surgery/unhealthy patient High acuity surgery/healthy patient High acuity surgery/unhealthy patient

Modified from COVID-19: Guidance for Triage of Non-Emergent Surgical Procedures. American College of Surgeons, Clinical Issues and Guidance (2)

General comments on cancer patients as they relate to the ESAS tier system:

  • Tier 3a or 3b (ESAS): All patients in this Tier should undergo appropriate procedures to remedy their urgent or emergent condition.**
  • Tier 2a or 2b (ESAS): The majority of cancer patients will fall in Tier 2. The guiding principle here is that these patients will require multidisciplinary input (done virtually as needed), and also that the surgeon carefully assess all variables listed above . Patients falling in the high-risk category, i.e. personal high-risk features or high-risk due to environment and resource issues (as outlined by the considerations above ), should preferentially be offered non-operative alternative measures in-lieu of surgery . If surgery cannot be avoided, measures to reduce inpatient LOS are recommended.***
  • Tier 1a or 1b (ESAS): All patients in this Tier are considered elective and should be delayed until pandemic is stabilized, resources are rebalanced, and risk is returning to baseline levels.

**When multiple options exist, especially for Tier 3b, the surgeon is encouraged to choose the treatment option that minimizes use of resources and decreases risk to patient and healthcare. (1)

***Disease site specific non-operative alternative measures are outlined below.

Site Specific Recommendations:

Management strategies for patients with Hepato-Pancreatic-Biliary (HPB) cancers during COVID-19 pandemic:

Generally, surgeons are encouraged to avoid operative management of HPB oncologic surgery in high risk patients (see variables noted above ) until locoregional pandemic status improves. It is worth noting that following the recommendations below may result in an endoscopic procedure, which harbors the risk of aerosolization, in-lieu of operative management. This is thought to be appropriate since it protects the overall resources used to manage patients in this pandemic. It goes without saying that healthcare providers performing any high-risk procedure should be equipped and follow strict PPE precautions as outlined in other recommendations. [https://www.sages.org/recommendations-surgical-response-covid-19/]

In the table below are various treatment options that are employed in treating HPB disease.

Treatment options in the HPB cancer patient include:
Liver
  • Resection (MIS, Open)
  • Transplantation
  • Chemotherapy
  • Ablation (percutaneous, MIS, open) (thermal, non-thermal)
  • Embolic therapies (radio-embolization, TACE)
  • Radiosurgery
  • Biliary stents
Pancreatico-Biliary
  • Resection (MIS, Open)
  • Transplantation (biliary)
  • Chemotherapy
  • Radiation therapy
  • Targeted & immunotherapies

The clinical presentation of the patient along with the stress on hospital resources by the COVID-19 patient volume will determine the best treatment option. While surgery has maintained its primacy in the treatment of HPB cancers, there are clearly roles for each of the above therapies, which may offer a preferred “next-best option” depending on the COVID-19 Phase of the hospital. For the purpose of this discussion we will exclude COVID-19 Phase 0 situations as that essentially falls into a business as usual category.

Treatment of common HPB conditions as it relates to COVID PHASE of Hospital or Healthcare System (see above for phase description):
Organ Clinical Situation Phase I Phase II Phase III
LIVER HCC (12)

Very early stage(0)/ Early Stage (A) / < 3cm *

*For later stages consider TACE, Medical therapy, supportive care as appropriate (e.

 Consider ablation/resection/transplant as appropriate Consider TACE, ablation, or observation (ie delay of definitive tx)
Colorectal mets (13, 14)

 

 Consider chemotherapy (Tier 2b or greater) vs resection (Tier 2a) Chemotherapy
BILIARY 15 Intrahepatic cholangiocarcinoma Consider chemotherapy (Tier 2b or greater) vs resection (Tier 2a) Consider chemotherapy, embolic therapy
Hilar cholangiocarcinoma Stenting as indicated.

resection, transplantation as indicated

 Stenting as indicated.

consider chemotherapy, chemoradiation, and/or transfer*
PANCREATIC AND EXTRA-HEPATIC BILIARY 16,17,18 Resectable Resection or consider chemotherapy Neoadjuvant chemotherapy
Borderline Neoadjuvant chemotherapy
Pancreatic IPMN, Cysts, low-mod grade neuroendocrine neoplasms All: observation (i.e. delay surgical management)

Neuroendocrine: if metastatic or progressing, consider targeted therapy

*transfer to a facility in a region in Phase 0 – II

Patients who have completed neoadjuvant treatment and are waiting for surgery – these patients are difficult to manage although from last chemotherapy to operation there is a window of up to 12 weeks during which surgery can be planned without losing the opportunity for potential cure. For some patients, consider discussing with the medical oncology team about adding an additional 1-2 cycles of chemotherapy to bridge the patient through the worst of this crisis and plan surgery thereafter (17). Alternatively, patients with borderline tumors who have completed their induction short course chemotherapy can undergo chemoradiation as indicated.(18)

General Comment

Optimally managing cancer patients within the confines of limited medical resources is a hurdle rarely encountered in modern times in the USA. Never before has our Hippocratic Oath come more into play. This document will be updated as new scenarios or suggestions are posted. Again, it is of paramount importance to recognize these as general recommendations are meant to be helpful to the surgeon, while recognizing that the individual surgeon and patient will need to decide upon the course of therapy depending upon local resources and individual situations.

We will all make difficult decisions and all stand behind one another, as we should always strive to do. Prioritizing the patient’s needs and wishes, the family, and standing by them in the surgeon-patient relationship whatever course is necessitated, remains our professional calling and commitment.

References:

  1. Kutikov A, Weinberg DS, Edelman MJ, et al. A War on Two Fronts: Cancer Care in the Time of COVID-19. Ann Intern Med. 2020; [Epub ahead of print 27 March 2020]. doi: https://doi.org/10.7326/M20-1133
  2. COVID-19: Guidance for Triage of Non-Emergent Surgical Procedures. American College of Surgeons, Clinical Issues and Guidance. https://www.facs.org/covid-19/clinical-guidance/triage online March 17 2020 and accessed Apr 1st 2020.
  3. Delaney CP, Chang E, Senagore AJ, et al. Clinical Outcomes and Resource Utilization Associated with Laparoscopic and Open Colectomy Using a Large National Database. Ann Surg. 2008; 247: 819 – 824.
  4. Gerber MH, Delitto D, Crippen CJ, et al. Analysis of the Cost Effectiveness of Laparoscopic Pancreatoduodenectomy. J Gastrointest Surg (2017) 21: 1404 – 1410.
  1. 1: Llovet JM. Updated treatment approach to hepatocellular carcinoma. J Gastroenterol. 2005 Mar;40(3):225-35. Review. PubMed PMID: 15830281.
  2. Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und–tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Fédération Francophone de Cancérologie Digestive (FFCD) Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2013;14:1208–1215.
  3. Liu W, Zhou JG, Sun Y, Zhang L, Xing BC. The role of neoadjuvant chemotherapy for resectable colorectal liver metastases: a systematic review and meta-analysis. Oncotarget. 2016;7:37277–37287.
  4. 15.McMasters KM, Tuttle TM, Leach SD, Rich T, Cleary KR, Evans DB, Curley SA. Neoadjuvant chemoradiation for extrahepatic cholangiocarcinoma. Am J Surg. 1997 Dec;174(6):605-8; discussion 608-9. PubMed PMID: 9409582.
  5. SWOG S1505: Initial findings on eligibility and neoadjuvant chemotherapy experience with mfolfirinox versus gemcitabine/nab-paclitaxel for resectable pancreatic adenocarcinoma. Davendra Sohal, Shannon McDonough, Syed A. Ahmad, Namita Gandhi, Muhammad Shaalan Beg, Andrea Wang-Gillam, James Lloyd Wade, Katherine A Guthrie, Andrew M. Lowy, Philip Agop Philip, and Howard S. Hochster Journal of Clinical Oncology 2019 37:4_suppl, 414-414.
  6. Rose JB, Rocha FG, Alseidi A, Biehl T, Moonka R, Ryan JA, Lin B, Picozzi V, Helton S. Extended neoadjuvant chemotherapy for borderline resectable pancreatic cancer demonstrates promising postoperative outcomes and survival. Ann Surg Oncol. 2014 May;21(5):1530-7. doi: 10.1245/s10434-014-3486-z. Epub 2014 Jan 29. Erratum in: Ann Surg Oncol. 2014 May;21(5):1538.
  7. 1: Oba A, Ho F, Bao QR, Al-Musawi MH, Schulick RD, Chiaro MD. Neoadjuvant Treatment in Pancreatic Cancer. Front Oncol. 2020 Feb 28;10:245. Doi: 10.3389/fonc.2020.00245. eCollection 2020. Review. PubMed PMID: 32185128; PubMed Central PMCID: PMC7058791.

SAGES Recommendations Regarding Surgical Management of Colorectal Cancer Patients During the Response to the COVID-19 Crisis

by

Note: these recommendations are subject to change and update.

Introduction

The care for all patients with cancer requires multidisciplinary review and decision-making, and entails the consideration of many factors in order to develop a sound plan of treatment. This requires a detailed assessment of patient, disease, surgical team, and hospital resources. (1) These principles remain critical and in fact, arguably more important now as we combat the COVID-19 pandemic than ever before. Thus a “one size fits all” recommendation would be unwise due to significant variability in patient presentation, individual comorbidities, disease severity, regional pandemic burden, and hospital-regional resources. It is important to recognize this document presents general recommendations. These are meant to be helpful to the surgeon while recognizing that the individual surgeon and patient will need to decide upon the course of therapy depending on local resources and individual situations.

The recommendations below are aimed to help guide practicing surgeons by providing a framework to address more urgent cancer cases, and to help stratify options that may diminish risk and improve outcomes. To address these concerns, we refer to several resources including the Elective Surgery Acuity Scale (ESAS) (2) as published by the American College of Surgeons (ACS).

As each surgeon assesses their patient, it should be kept in mind that at of the date of this publication, no region in the USA is thought to have peaked in this epidemic. Thus, conditions are expected to get worse before improving. Having said that, when areas experience a “flattening of the curve”, some non-emergent surgeries may be considered.

ESSENTIAL POINTS TO HELP WITH CANCER CARE TRIAGE

Important Considerations for all Cancer Patients:

  1. The comorbidities and age of the patient are paramount in assessing the relative risk and benefit of exposing the patient to coronavirus versus pursuing alternative, next-best options such as neoadjuvant chemotherapy prior to operation.
  2. The resources available to the surgeon and hospital at the time of assessment are also critical. Since this pandemic is dynamic in terms of patient acuity, volume, and hospital resources, the current state and immediate potential future state of the hospital system at the time of the proposed operation and anticipated postoperative inpatient recovery needs to be considered.
COVID-19 PHASE of Hospital or Healthcare System:
Phase Condition Description
0 Unaffected No COVID-19 patients, hospital operating as normal
I Semi-urgent COVID-19 patients are in the hospital, but resources and ICU beds/ventilators are not threatened
II Urgent Many COVID-19 patients are in the hospital, ICU beds/ventilator availability is strained and operative and/or PPE resources are limited
III Emergent Crisis situation where most ICU/ventilator resources are directed to COVID-19 patients and operating room and/or PPE equipment are minimally or entirely unavailable
  1. The urgency of the operation proposed. Most hospital systems are endorsing that, as hospital resources allow, patients with cancer should undergo curative resection if delaying surgery by more than 3 months will adversely impact tumor and oncologic outcomes.
  2. Testing for coronavirus prior to operation is strongly encouraged, contingent on testing availability. This is encouraged as a precaution for your patients who may be about to become ill, as well as for staff and the surgical provider, who need to be stewarded as fundamental workforce resources for our patients. A complex surgical procedure will likely affect a patient’s immune system, and deferral should be considered for COVID-positive patients until the COVID disease process has stabilized.
  3. Open surgery and minimally invasive approaches – Consideration should be given when performing open, laparoscopic or robotic surgical approaches to risks of aerosolization of the virus. As long as the patient is negative for the virus either approach is appropriate. However, for patients who are positive for the virus and require more urgent operation, each approach has its own considerations. Concerns exist regarding potential viral contamination with pneumoperitoneum during laparoscopic and robotic surgery. Even though there is no clear evidence it occurs with COVID-19, the risk cannot be overlooked and there are ways of mitigating the risk as we previously described (see link below). During open surgery, the risk of viral spread within the plumes generated by electrosurgery or other energy sources is also to be considered. Robotic approaches in confirmed or suspected COVID-19 patients also had the added consideration of potential contamination of the robotic equipment. https://www.sages.org/resources-smoke-gas-evacuation-during-open-laparoscopic-endoscopic-procedures/; https://www.sages.org/recommendations-surgical-response-covid-19/
  4. Likelihood for need of ICU – Patients who are expected to require significant time in the hospital, or have a higher risk of peri-operative complications potentially requiring ICU or step-down unit/telemetry services that may be needed for acutely ill COVID patients, should be have their operation timed to avoid surge resource constraints and contamination, if possible.
  5. Length of time for recovery – The benefits of MIS surgery with reduced hospital stay and higher rate of discharge to home, rather than a nursing home, should be considered in planning surgical approaches. (3, 4)
  6. Consenting the patient for surgery – The potential risks and implications of doing surgery during the COVID-19 pandemic, particular to the local institution, should be clearly discussed with the patient and family when obtaining consent for surgery.

General management strategies for patients with cancer during COVID-19 pandemic (Tier-based):

Generally, cancer patients require resources and support services that are typically stressed during pandemics. Further, early reports in this pandemic show that viral infection with COVID-19 tends to be specifically more lethal in cancer patients (5). This highlights that surgeons and systems must recognize that all cancer patients are in a high-risk category.

Tier 1a Tier 1b Tier 2a Tier 2b Tier 3a Tier 3b
Low acuity surgery/healthy patient

Outpatient surgery

Not life- threatening illness

 Low acuity surgery/unhealthy patient Intermediate acuity surgery/healthy patient

Not life threatening but potential for future morbidity and mortality.

Requires in hospital stay

 Intermediate acuity surgery/unhealthy patient High acuity surgery/healthy patient High acuity surgery/unhealthy patient

Modified from COVID-19: Guidance for Triage of Non-Emergent Surgical Procedures. American College of Surgeons, Clinical Issues and Guidance (2)

General comments on cancer patients as they relate to the ESAS tier system:

  • Tier 3a or 3b (ESAS): All patients in this Tier should undergo appropriate procedures to remedy their urgent or emergent condition.**
  • Tier 2a or 2b (ESAS): The majority of cancer patients will fall in Tier 2. The guiding principle here is that these patients will require multidisciplinary input (done virtually as needed), and also that the surgeon carefully assess all variables listed above . Patients falling in the high-risk category, i.e. personal high-risk features or high-risk due to environment and resource issues (as outlined by the considerations above ), should preferentially be offered non-operative alternative measures in-lieu of surgery . If surgery cannot be avoided, measures to reduce inpatient LOS are recommended.***
  • Tier 1a or 1b (ESAS): All patients in this Tier are considered elective and should be delayed until pandemic is stabilized, resources are rebalanced, and risk is returning to baseline levels.

**When multiple options exist, especially for Tier 3b, the surgeon is encouraged to choose the treatment option that minimizes use of resources and decreases risk to patient and healthcare. (1)

***Disease site specific non-operative alternative measures are outlined below.

Site Specific Recommendations:

I.Management strategies for patients with Colorectal Cancers during COVID-19 pandemic:

Below is a discussion of treatment options and guidelines to consider for patients with newly diagnosed colorectal cancers, including patients who are completing or have already completed neoadjuvant treatment. The best treatment for the patient will vary depending on the individual situation as well as the phase of COVID-19 in your region, including patient volume and the resulting strain on the hospital and its resources.

To set the groundwork for the discussion it is worthwhile to list various treatment options and clinical scenarios. It is helpful to categorize conditions surrounding the hospital and healthcare system in an effort to choose treatments wisely.

Treatment options in the colorectal cancer patient include:

  1. 1. Definitive Oncologic Surgery
  2. 2. Delay of Treatment (6, 7)
  3. 3. Stent Placement (8, 9)
  4. 4. Diverting Stoma
  5. 5. Induction Chemotherapy (10)
    1. a. Duration & extended course (1 or 2 more cycles)
  6. 6. Chemoradiation (rectal cancer)
    1. Short course vs. long course (11)

The clinical presentation of the patient along with COVID-related strain on hospital resources will determine the most appropriate plan of action. While surgery maintains its primacy in the treatment of colorectal cancer, there are clearly roles for each of the above therapies, which may offer the preferred “next-best option” based on the COVID-19 Phase of the institution. For the purpose of this discussion we will exclude COVID-19 Phase 0 situations, which fall into a “business as usual” category.

Treatment of common colorectal conditions as it relates to COVID-19 PHASE of Hospital or Healthcare System (see above for phase description):
Clinical Situation Phase I Phase II Phase III
Large or suspicious polyps

Hereditary Syndromes

Dysplasia/Carcinoma in situ in biopsy specimens,

Incomplete, questionable margins on polypectomy

  

 

All of the above categories would be classified as Tier 1or 2a, and for COVID-19 Phase I – III Hospitals surgery would be delayed until the pandemic abates and resources return
Early cancer in resected polyp: (Tier 2) Consider deferring surgery vs resection Defer Surgery
Asymptomatic Cancer

T1-2 N0 (Tier 2)

 Resect Resect Vs Deferring surgery Defer Surgery
Asymptomatic Cancer

Colon T3-4, N0 and Tx N+ (Tier 2)

 Resect Resect Vs Deferring surgery** Consider Chemotherapy Vs transfer*
Rectal T3-4, N0 and Tx N+ (Tier 2) Induction chemotherapy versus chemoradiation versus radiation, consider extended chemotherapy, also consider delaying surgery up to 12-16 weeks following completion of radiation
Symptomatic Cancers (Tier 3) defined as bleeding requiring transfusion, obstructing or near-obstructing, impending perforation Resect Resect, consider stent versus stoma Stoma vs stent, Consider transfer*

*transfer to a facility in a region in Phase 0-II

**While resection of locally advanced colon malignancies may be feasible during Phase II, the decision to defer may be justified based on anticipated impending COVID-19 surge and critical straining on institutional resources (transition from Phase II to Phase III may occur within days)

General Comment

Optimally managing cancer patients within the confines of limited medical resources is a hurdle rarely encountered in modern times in the USA. Never before has our Hippocratic Oath come more into play. This document will be updated as new scenarios or suggestions are posted. Again, it is of paramount importance to recognize these as general recommendations are meant to be helpful to the surgeon, while recognizing that the individual surgeon and patient will need to decide upon the course of therapy depending upon local resources and individual situations.

We will all make difficult decisions and all stand behind one another, as we should always strive to do. Prioritizing the patient’s needs and wishes, the family, and standing by them in the surgeon-patient relationship whatever course is necessitated, remains our professional calling and commitment.

References

  1. Kutikov A, Weinberg DS, Edelman MJ, et al. A War on Two Fronts: Cancer Care in the Time of COVID-19. Ann Intern Med. 2020; [Epub ahead of print 27 March 2020]. doi: https://doi.org/10.7326/M20-1133
  2. COVID-19: Guidance for Triage of Non-Emergent Surgical Procedures. American College of Surgeons, Clinical Issues and Guidance. https://www.facs.org/covid-19/clinical-guidance/triage online March 17 2020 and accessed Apr 1st 2020.
  3. Delaney CP, Chang E, Senagore AJ, et al. Clinical Outcomes and Resource Utilization Associated with Laparoscopic and Open Colectomy Using a Large National Database. Ann Surg. 2008; 247: 819 – 824.
  4. Gerber MH, Delitto D, Crippen CJ, et al. Analysis of the Cost Effectiveness of Laparoscopic Pancreatoduodenectomy. J Gastrointest Surg (2017) 21: 1404 – 1410.
  5. Liang W, Guan W, Chen R, et al. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020;21:335-337. [PMID: 32066541] doi:10.1016/S1470-2045(20)30096-6.
  6. Helewa RM, Turner D, Park J, et al. Longer Waiting Times for Patients Undergoing Colorectal Cancer Surgery Are Not Associated With Decreased Survival. Journal of Surgical Oncology. 2013; 108:378-384.
  7. Simunovic M, Rempel E, Theriault ME, et al. Influence of delays to nonemergent colon cancer surgery on operative mortality, disease specific survival and overall survival. Can J Surg, Vol. 52, No. 4, August 2009.
  8. Allievi N, Ceresoli M, Fugazzola P, et al. Endoscopic Stenting as Bridge to Surgery versus Emergency Resection for Left-Sided Malignant Colorectal Obstruction: An Updated Meta-Analysis. International Journal of Surgical Oncology. 2017.
  9. Choi JM, Lee C, Han YM et al (2014) Long-term oncologic outcomes of endoscopic stenting as a bridge to surgery for malignant colonic obstruction: comparison with emergency surgery. Surg Endosc 28:2649–2655.
  10. Ludmir EB, Palta M, Willet CG, Czito BG. Total neoadjuvant therapy for rectal cancer: An emerging option. Cancer. 2017; 123(9): 1497 – 1506.
  11. “Short-Course RadiationVersus Long-Course Chemoradiation for Rectal Cancer: Making Progress.” Journal of Clinical Oncology, 30(31), pp. 3777–3778.
  12. 12 1: Llovet JM. Updated treatment approach to hepatocellular carcinoma. J Gastroenterol. 2005 Mar;40(3):225-35. Review. PubMed PMID: 15830281.
  13. Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und–tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Fédération Francophone de Cancérologie Digestive (FFCD) Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal

SAGES Joins Pilot to Improve Colorectal Cancer Screening Rates

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SAGES Joins Pilot to Improve Colorectal Cancer Screening Rates, Access to Specialty Care in Community Health Centers

SAGES has joined with the American Cancer Society and the National Colorectal Cancer Roundtable to implement a colorectal cancer screening pilot program in underserved communities.

The program is part of NCCR’s effort to reach the goal of 80 percent of adults 50 and over receiving regular screening for colorectal cancer by 2018.   Pilots will be launched in South Carolina, Connecticut and Minnesota.

SAGES played an instrumental role helping to define the problem, craft the grant process, and educate roundtable participants that general surgeons provide the majority of colonoscopy screening in underserved communities in the US.

“We are honored to be a part of this national roundtable of foremost experts in the field of colon cancer prevention and treatment,” said Dr. Michael Brunt, SAGES President. “Early screening is essential to prevention and colorectal cancer is the only one of the five most common cancers that can actually be prevented by screening.

According to Dr. Brian Dunkin, SAGES President-Elect, “This pilot program will help to bring services to communities most in need, and SAGES has committed to helping to identify surgical endoscopists within our rank that are willing to provide colonoscopy screening to the underserved at these healthcare clinics.”