Clinical Spotlight Review: Endoluminal Treatments for Gastroesophageal Reflux Disease (GERD)

This document was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in May 2017.

Authors:

Jonathan Pearl MD
Eric Pauli MD
Brian Dunkin MD
Dimitrios Stefanidis MD

Gastroesophageal reflux disease (GERD) is a common problem that affects approximately 30-40% of the adult population with at least 20% of Americans reporting weekly symptoms.1,2 GERD accounts for 8.9 million annual outpatient visits with an estimated annual cost of 24 billion dollars.2 For upper gastrointestinal endoscopy alone, the cost to the health care system is estimated at $12.3 billion annually.3 First-line therapy for GERD includes a combination of lifestyle modifications and medical therapy, with antireflux medications accounting for approximately $7.7 billion in annual US health care costs.4 GERD often requires lifelong treatment and is associated with serious health risks including esophagitis, esophageal stricture, Barrett’s, and adenocarcinoma of the esophagus.

Unfortunately, 25% to 42% of patients with GERD do not respond to an initial 4-8 week treatment with proton pump inhibitors (PPI).5 In those who do respond to therapy, the effectiveness of PPI treatment decreases over time. Antireflux surgery controls acid reflux and treats an incompetent lower esophageal sphincter, while improving patient quality of life in the long-term.6,7 Thus, PPI therapy and lifestyle modifications are frequently eliminated.

Despite the effectiveness of surgery, it is invasive, requires hospitalization, and carries the risk of short and long-term complications, including dysphagia, diarrhea, and gas bloat syndrome.8,9 Thus, endoscopic therapies that mimic the mechanism through which surgery works and can reduce surgical morbidity have gained popularity for the treatment of GERD. Popular endoscopic treatments include the Esophyx device and Stretta. In 2013, the SAGES Guidelines Committee published a review of the available evidence on these two procedures.10 Since numerous, quality studies and vast literature accumulation have arisen since the previous SAGES publication, the SAGES Guidelines Committee decided to update its recommendations on these techniques. The new document will address the evidence around Stretta and Esophyx, as well as provide evidence-based answers to the following clinically relevant questions that were developed by the SAGES Guidelines Committee using the PICOD methodology:11

  1. In adults or children with primary or post-surgical GERD, how do endoscopic treatments compare with continued medical treatment or antireflux surgery for symptom control, resolution, or recurrence; quality of life and related outcomes; and long-term GERD complications?
  2. How safe are endoluminal treatments?
  3. How does the comparative effectiveness change with longer follow-up duration?
  4. How does the comparative effectiveness differ based on the surgeon’s experience?

Methodology

A systematic literature search was performed in July 2016 on Stretta and EsophyX. Only English articles were retrieved. Two members of the SAGES guidelines committee reviewed the retrieved abstracts and pulled the full text of relevant articles for detailed review. Both the quality of the evidence and the strength of the recommendation for each of the below guidelines was assessed according to the GRADE system. There is a 4-tiered system for quality of evidence (very low (+), low (++), moderate (+++), or high (++++)) and a 2-tiered system for strength of recommendation (weak or strong).

A. EsophyX

EsophyXTM, developed by Endogastric Solutions (Redwood City, WA) and approved by the FDA in 2007, is an endoscopic device used to create a transoral incisionless fundoplication (TIF). It is inserted orally within a thin, flexible tube and deployed inside the stomach to create a full thickness plication of the stomach fundus at the GE junction, thereby resembling an endoscopic fundoplication. The current TIF 2.0 technique (the initial TIF 1.0 technique is no longer recommended) generates a physiological valve via fasteners placed on the far posterior and anterior sides of the lesser curvature, with additional fasteners placed 1–3 cm proximal to the GE junction (Figure 1). The polypropylene “H-shaped” fasteners aid the “serosa to serosa” fusion and promote the reconstruction of an anatomical valve similar to traditional fundoplication.

Under general anesthesia, the procedure is typically accomplished in less than an hour and requires a surgeon to operate the device, while an assistant operates the gastroscope. Patients can return to work and normal activities within a few days, making TIF an attractive option for the treatment of GERD.

Since the introduction of TIF in clinical practice, numerous studies have reported on its outcomes. A systematic literature search of the available evidence revealed sixty papers on TIF. Since the publication of the prior SAGES report on endoluminal techniques,10 five randomized controlled trials, 12-16 one systematic review, 17 and one meta-analysis 18 have been published. These studies provide a clearer picture of the clinical effectiveness and safety of the procedure. Moreover, eight observational studies and an additional systematic review provide insight into longer term outcomes of the TIF 2.0 procedure. In the following text we will address the questions pertinent to this procedure.

Question #1:

 

In adults or children with primary or post-surgical GERD, how does TIF 2.0 compare with continued medical treatment or antireflux surgery for symptom control, resolution, or recurrence; quality of life and related outcomes; and long-term GERD complications?

Symptom control

All available randomized controlled trials have compared TIF 2.0 with medical treatment (PPI), but no study has compared it with surgical fundoplication. There is significant heterogeneity in the primary outcomes of the five available RCTs. Two of the trials assessed elimination of troublesome regurgitation,12,13 one assessed clinical remission of GERD without PPIs,14 one assessed improvement in GERD symptom scores,15 and one assessed the changes in baseline impedance and heartburn severity.16 To compare the results of the available RCTs, a meta-analysis18 was conducted in which the primary outcome was the responsiveness of GERD to TIF treatment versus control intervention. They defined responsiveness as an improvement of at least 50% in the GERD health-related quality of life (GERD-HRQL) scores, remission of heartburn and regurgitation, or in the absence of these reported outcomes, complete cessation of PPI use. Among patients included in four of the available RCTs,12-15 those who underwent TIF were more likely to attain the standard of responsiveness at six months compared with the control group treated with PPIs (66% vs 30.5%, respectively; pooled RR: 2.44, 95% CI: 1.25–4.79, p = 0.009).18 Compared with PPI treatment, TIF has clearly demonstrated to be more effective in controlling patient GERD symptoms six months post-procedure.

Objective outcomes

Compared with sham controls (mean difference: -4.25, 95% CI: -7.87 to -0.63, I2=78%, p= 0.02), esophageal acid exposure time has been shown to improve significantly after TIF and be similar to that of patients on PPIs (mean difference: -0.34, 95% CI: -4.02 to 3.33, I2= 87%, p= 0.85). Concerning the total number of reflux episodes, patients undergoing TIF were found to have fewer episodes compared with those on PPIs, with a mean difference of -29.07 (95%CI: -39.17 to -18.98, I2=45%, p<0.00001). The incidence of acid reflux episodes reveals no significant differences between TIF and PPI treatment with a mean difference of 10.43 (95% CI: -4.02 to 24.88, I2= 0%, p= 0.16).18

Satisfaction

As reported in ten observational studies, patient satisfaction is between 45 and 86% at a mean of six months after the TIF procedure, with a calculated weighted average rate of 69.15%.18

Considerations for the pediatric population

A small, retrospective cohort study has reported TIF outcomes in neurologically impaired children with GERD. At a follow-up of 8.2 ± 4.2 months, the authors found that TIF effectively resolved GERD in ten out of eleven children.19 However, the EsophyX System is not approved by the FDA for use in pediatric patients, nor does the manufacturer recommend its use in children. The device itself requires a 54-French diameter delivery system, limiting application to patients larger than 25 kg, thereby excluding infants and toddlers. Presently, there is insufficient data to support the use of TIF in the pediatric population.

There are no quality studies available that compare TIF to surgical fundoplication, nor does evidence exist regarding the impact of TIF on long term complications of GERD such as Barrett’s esophagus, stricture formation, or cancer. All studies used TIF for the primary treatment of GERD and no evidence exists for post-surgical GERD treatment. The most recent SAGES guidelines on the treatment of GERD23 indicate that the effectiveness of laparoscopic fundoplication on GERD outcomes is superior to that of PPIs and TIF.

Question #2:

 

How safe is TIF 2.0?

Sixteen studies (4 RCTs and 12 prospective observational trials)18 have reported the occurrence of severe adverse events. Of a total of 781 patients who underwent TIF, severe adverse events occurred in 19 patients, yielding an incidence rate of 2.4%. Severe adverse events included seven perforations, five instances of post-TIF bleeding, four cases of pneumothorax, one requiring intravenous antibiotics, and one case involving severe epigastric pain. One death was reported 20 months after the TIF procedure, with an unknown causal relationship.

A potential concern is that a failed TIF may increase the risk of a subsequent fundoplication, which might result from scarring and the presence of H fasteners. Three studies have reported outcomes after failed TIF and have demonstrated that fundoplication can be accomplished safely and effectively. Reasons for failure during surgery often include breakdown of fundoplication and the presence of a hiatal hernia. 20-22

Question #3:

 

How does the comparative effectiveness of TIF 2.0 change with longer follow-up duration?

Based on the findings of the meta-analysis that also examined long-term outcomes after the procedure reported by observational studies, the effectiveness of the procedure diminishes over time reaching a maximum level just over 70% at six months and just under 40% six years later. Six year outcomes have been reported on only 14 patients. Although most of the patients resumed PPI treatment during the long-term follow-up, PPI doses were reduced compared with their baseline.18

 

Question #4:

 

How does the comparative effectiveness of TIF 2.0 differ based on the surgeon’s experience?

There are no reports directly addressing this question. The initial TIF 1.0 technique that created a gastro-gastric plication with fasteners fixed centrally on the greater curvature at the squamocolumnar junction of the esophagus to the gastric fundus did not work as well for reflux control and is no longer recommended. The TIF 2.0 technique generates a physiological valve via fasteners placed on the far posterior and anterior sides of the lesser curvature, with additional fasteners placed 1–3 cm proximal to the GE junction. Since the number of fasteners appear to affect GERD outcomes, at least 14 H fasteners are recommended to be placed during the procedure.24

Recommendation:

Based on existing evidence, TIF can be performed with an acceptable safety risk in appropriately selected patients. The procedure leads to better control of GERD symptoms compared with PPI treatment in the short term (6 months), but appears to lose effectiveness during longer term follow-up and is associated with moderate patient satisfaction scores. Objective GERD measures improve similarly after TIF 2.0 compared with PPI. No comparative, controlled trials exist between TIF and surgical fundoplication, but preliminary evidence suggests that the latter can be used safely after TIF failure. (Level of evidence +++, strong recommendation)

References:

  1. Pohle T and Domschke. Results of short- and long-term medical treatment of gastroesophageal reflux disease (GERD). Langenbeck’s Archive of Surgery. 2000. 385: 317-323.
  2. Brook RA, Wahlqvist P et al. Cost of gastro-oesophgeal reflux disease to the employer: A prospective from the United States. Alimentary Pharmacology and Therapeutics. 2007. 26: 889-898.
  3. Peery AF, Dellon ES, Lund J, et al. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012. 143:1179–1187.e1–3.
  4. Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part I: Overall and upper gastrointestinal diseases. Gastroenterology. 2009. 136: 376–386.
  5. Richter JE. The patient with refractory gastroesophageal reflux disease. Dis Esophagus 2006;19:443–447.
  6. Papasavas PK, Keenan RJ et al. Effectiveness of laparoscopic fundoplication in relieving the symptoms of gastroesophageal reflux disease (GERD) and eliminating antireflux medical therapy. Surgical Endoscopy. 2003. 17. 1200 – 1205.
  7. Dallemagne B, Weerts J et al. Clinical results of laparoscopic fundoplication at ten years after surgery. Surgical Endoscopy. 2006. 20. 159-165.
  8. Herron DM, Swanstrom LL, Ramzi N, et al. Factors predictive of dysphagia after laparoscopic Nissen fundoplication. Surg Endosc 1999;13:1180–1183.
  9. Granderath FA, Kamolz T, Granderath UM, et al. Gas-related symptoms after laparoscopic 360 degrees Nissen or 270 degrees.Toupet fundoplication in gastroesophageal reflux disease patients with aerophagia as comorbidity. Dig Liver Dis 2007; 39:312–318.
  10. Auyang ED, Carter P, Rauth T, Fanelli RD. SAGES clinical spotlight review: endoluminal treatments for gastroesophageal reflux disease (GERD). Surg Endosc. 2013 Aug;27(8):2658-72.
  11. Huang X, Lin J, Demner-Fushman D (2006). “Evaluation of PICO as a knowledge representation for clinical questions”. AMIA Annu Symp Proc: 359–63.
  12. Hunter JG, Kahrilas PJ, Bell RC, Wilson EB, Trad KS, Dolan JP, Perry KA, Oelschlager BK, Soper NJ, Snyder BE, Burch MA, Melvin WS, Reavis KM, Turgeon DG, Hungness ES, Diggs BS. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology. 2015; 148(2):324-333.e5.
  13. Trad KS, Barnes WE, Simoni G, Shughoury AB, Mavrelis PG, Raza M, Heise JA, Turgeon DG, Fox MA. Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO Randomized Clinical Trial. Surg Innov. 2015 Feb;22(1):26-40.
  14. Håkansson B, Montgomery M, Cadiere GB, Rajan A, Bruley des Varannes S, Lerhun M, Coron E, Tack J, Bischops R, Thorell A, Arnelo U, Lundell L. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther. 2015 Dec;42(11-12):1261-70.
  15. Witteman BP, Conchillo JM, Rinsma NF, Betzel B, Peeters A, Koek GH, Stassen LP, Bouvy ND. Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2015 Apr;110(4):531-42.
  16. Rinsma NF, Smeets FG, Bruls DW, Kessing BF, Bouvy ND, Masclee AA, Conchillo JM. Effect of transoral incisionless fundoplication on reflux mechanisms. Surg Endosc. 2014 Mar;28(3):941-9.
  17. Wendling MR, Melvin WS, Perry KA. Impact of transoral incisionless fundoplication (TIF) on subjective and objective GERD indices: a systematic review of the published literature. Surg Endosc. 2013 Oct;27(10):3754-61.
  18. Huang X, Chen S, Zhao H, Zeng X, Lian J, Tseng Y, Chen J. Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GERD: a systematic review with meta-analysis. Surg Endosc. 2016 Aug 5 (Epub)
  19. Chen S, Jarboe MD, Teitelbaum DH. Effectiveness of a transluminal endoscopic fundoplication for the treatment of pediatric gastroesophageal reflux disease. Pediatr Surg Int. 2012;28(3):229-34.
  20. Perry KA, Linn JG, Eakin JL, Onders RP, Velanovich V, Melvin WS.Transoral incisionless fundoplication does not significantly increase morbidity of subsequent laparoscopic Nissen fundoplication. J Laparoendosc Adv Surg Tech A. 2013 May;23(5):456-8.
  21. Bell RC, Kurian AA, Freeman KD. Laparoscopic anti-reflux revision surgery after transoral incisionless fundoplication is safe and effective. Surg Endosc. 2015 Jul;29(7):1746-52.
  22. Ashfaq A, Rhee HK, Harold KL. Revision of failed transoral incisionless fundoplication by subsequent laparoscopic Nissen fundoplication. World J Gastroenterol. 2014 Dec 7;20(45):17115-9.
  23. Stefanidis D, Hope WW, Kohn GP, Reardon PR, Richardson WS, Fanelli RD; SAGES Guidelines Committee. Guidelines for surgical treatment of gastroesophageal reflux disease. Surg Endosc. 2010; 24(11):2647-69.
  24. Testoni PA, Mazzoleni G, Testoni SGG. Transoral incisionless fundoplication for gastro-esophageal reflux disease: Techniques and outcomes. World J Gastrointest Pharmacol Ther. 2016 May 6; 7(2): 179–189.

B. Stretta

The transoral Stretta catheter system delivers radiofrequency (RF) energy around the lower esophageal sphincter (LES) by forcing radially placed needles on a balloon into the area multiple times and at multiple levels (figure 2). It uses a proprietary algorithmic application of low power (5 Watts) RF energy that heat tissue (65°C to 85°C) during a series of one-minute treatment cycles. Stretta therapy leads to remodeling of the musculature of the LES and gastric cardia. The mechanism of action is believed to be related to decreased sensitivity to acid, decreased compliance of the LES or increased pressure of the LES.1,2,3 The FDA originally cleared Stretta for use in 2000 and issued an updated clearance on the RF generator in 2011.

Under conscious sedation, the procedure is typically accomplished in less than an hour. Patients can return to home within a few hours and to work and normal activities within 24 hours, making Stretta an attractive option for the treatment of GERD.

Since the introduction of Stretta in clinical practice, numerous studies have reported on its outcomes. A systematic literature search of the available evidence revealed 117 papers on Stretta. Since the publication of the prior SAGES report on endoluminal techniques,26 two new systematic reviews and meta-analyses,18,20 four new observational studies reporting longer term follow up results,7,10,13,23 but no new randomized controlled trials have been published. These studies provide a clearer picture of the clinical effectiveness and safety of the procedure. In the following text we will address the key questions pertinent to Stretta.

Question #1:

 

In adults or children with primary or post-surgical GERD, how does Stretta compare with continued medical treatment or antireflux surgery for symptom control, resolution, or recurrence; quality of life and related outcomes; and long-term GERD complications?

Of the two available, recent systematic reviews and meta-analyses that have analyzed the existing literature on Stretta, one has included both randomized and observational studies20 similar to a prior systematic review that was included in our previous report 17 and one analyzed only the 4 existing randomized trials.18 This difference in inclusion criteria has led to fairly disparate conclusions of these studies.

In patients with GERD, one study18 did not demonstrate a difference between Stretta and sham or management with PPI for the outcomes of mean (%) time the pH was less than 4 over a 24-hour time course, lower esophageal sphincter pressure (LESP), ability to stop PPIs, or health related quality of life (HRQOL). Nevertheless, all these outcomes except for the mean (%) time the pH was less than 4 over a 24-hour period, were in favor of Stretta and approached, but did not reach statistical significance. The small sample size, which analyzed only 153 patients, is the main limitation of the meta-analysis. Recent studies have also argued that observational studies should be pooled with randomized trials during meta-analyses.20,22

The most recent systematic review and meta-analysis20 included studies from a variety of geographic locations and institutions and provides a generalizable picture of the effectiveness of Stretta. The meta-analysis analyzed outcomes of 2,468 patients from 4 randomized and 24 observational studies who had undergone the Stretta procedure with an (unweighted) mean follow up time of 25.4 [14.0, 36.7] months. The pooled results showed that the Stretta procedure reduced (improved) the health-related quality of life score by -14.6 [-16.48, -12.73] (P<0.001) and reduced the pooled heartburn standardized score by -1.53 [-1.97, -1.09] (P<0.001). After Stretta treatment, half of the patients using PPIs at baseline required PPIs at follow-up (P<0.001). The Stretta treatment reduced the incidence of erosive esophagitis by 24% (P<0.001) and reduced esophageal acid exposure by a mean of -3.01 [-3.72, -2.30] (P<0.001). On the other hand, lower esophageal sphincter basal pressure was increased post Stretta therapy by a mean of 1.73 [-0.29, 3.74] mmHg, but this change was not statistically significant (P=NS).

Using a Markov model to assess the long term cost effectiveness of therapies such as PPI, Stretta, EsophyX and laparoscopic Nissen fundoplication for GERD,19 it was demonstrated that assuming a PPI cost of $234 over 6 months ($39 per month), PPI, Stretta and laparoscopic Nissen fundoplication were the most cost-effective options over a 30-year time period. When the PPI cost, however, exceeded $90 per month, medical therapy was no longer cost effective.

Compared to fundoplication, Stretta is less effective for GERD symptom control but has fewer complications.6 Stretta has also been applied to the treatment of GERD after prior antireflux surgery9 or after bariatric surgery10 with promising results. Few papers have also reported Stretta application to pediatric patients with reported improvements in GERD symptoms.11,12

It is also important to note that in most of the trials, Stretta was used in patients with less than severe esophagitis and with <2 cm hiatal hernias. As described previously, although Stretta improves the majority of GERD indices, it does not often lead to their normalization.

Question #2:

 

How safe is Stretta?

One meta-analysis20 identified 23 complications in 2,468 reported cases, for an incidence of 0.93%. Most of the identified complications were minor and included small erosions (0.36%) or lacerations (0.28%) of the mucosa and rarely prolonged gastroparesis (0.12%), pneumonia, bleeding ulcer, or mediastinitis (for all 0.04%). No mortalities have been reported. Another meta-analysis18 assessed the US Food and Drug Administration Manufacturer and User Facility Device Experience database for reported complications related to Stretta. (US Food and Drug Administration. MAUDE – Manufacturer and User Facility Device Experience. 2014. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm). They identified 21 reported adverse events such as pneumonia, gastroparesis, esophageal perforation, and cardiac arrest, resulting in several hospitalizations, some permanent damages, and 4 deaths. It was, however, unclear whether these complications were solely related to the procedure and what the total number of procedures was that these complications originated from. At the time of the publication,18 an estimated 20,000 Stretta procedures had been performed globally,25 which would bring the MAUDE complication incidence tof less than 1%.

 

Question #3:

 

How does the comparative effectiveness of Stretta change with longer follow-up duration?

The majority of published studies about Stretta have a short follow-up period (up to 12 months). While none of the 4 published RCTs report outcomes beyond 12 months, several observational studies do,6,7,13,14,15,16,17 with the longest available follow up duration being 10 years.7 The latter study prospectively assessed 217 patients with medically refractory GERD before Stretta. The primary outcome of normalization of GERD-health-related quality of life (GERD-HRQL) was achieved in 72% of patients (95% confidence interval 65-79) 10 years after the Stretta procedure. In addition, the same authors reported that a 50% or greater reduction in PPI use occurred in 64% of patients, (41% eliminating PPIs entirely), and a 60% or greater increase in satisfaction occurred in 54% of patients. The study also showed that pre-existing Barrett’s metaplasia regressed in 85% of biopsied patients. Further, in a comparative cohort study of 125 patients who had undergone Stretta or laparoscopic Toupet fundoplication, both groups achieved similar independence from PPI treatment at 3 years follow up (68% vs 72%, respectively; p=ns), but the fundoplication was superior in the control of typical reflux symptoms and reduced the rate of reoperation (12% vs 0%, respectively; p=0.006).23 All available cohort studies with follow up longer than 4 years13,7,16,10,15 indicate that the effectiveness of the procedure persists in the long term, to a degree somewhat less than that achieved initially. One of these studies15, however, suggested that the best results are achieved in select patients with less severe GERD at baseline.

 

Question #4:

 

How does the comparative effectiveness of Stretta differ based on the surgeon’s experience?

Few articles have reported on the learning curve of the Stretta procedure. In terms of time taken to complete Stretta, the reported learning curve appears to be less than 5 cases.24 Further, the technique itself does not appear to affect procedural outcomes as long as the application guidelines are followed.

Recommendation:

Based on existing evidence, Stretta significantly improves health related quality of life score, heartburn scores, the incidence of esophagitis, and esophageal acid exposure in patients with GERD, but does not increase lower esophageal sphincter basal pressure. In addition, it decreases the use of PPI by approximately 50%. The effectiveness of the procedure diminishes some over time, but persistent effects have been described up to 10 years after the procedure in appropriately selected patients with GERD. Stretta is more effective than PPI, but less so than fundoplication. Stretta is safe in adults and has a short learning curve. (Level of evidence +++, strong recommendation)

References:

  1. Arts J1, Sifrim D, Rutgeerts P, Lerut A, Janssens J, Tack J. Influence of radiofrequency energy delivery at the gastroesophageal junction (the Stretta procedure) on symptoms, acid exposure, and esophageal sensitivity to acid perfusion in gastroesophageal reflux disease. Dig Dis Sci. 2007 Sep;52(9):2170-7. Epub 2007 Apr 12. 2.
  2. Arts J, Bisschops R, Blondeau K, Farré R, Vos R, Holvoet L, Caenepeel P, Lerut A, Tack J. A double-blind sham-controlled study of the effect of radiofrequency energy on symptoms and distensibility of the gastroesophageal junction in GERD. Am J Gastroenterol. 2012 Feb;107(2):222-30.
  3. Aziz AM, El-Khayat HR, Sadek A, Mattar SG, McNulty G, Kongkam P, Guda MF, Lehman GA. A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease. Surg Endosc. 2010 Apr;24(4):818-25.
  4. Houston H, Khaitan L, Holzman M, Richards WO. First year experience of patients undergoing the Stretta procedure. Surg Endosc. 2003 Mar;17(3):401-4. Epub 2002 Nov 20.
  5. Triadafilopoulos G, DiBaise JK, Nostrant TT, Stollman NH, Anderson PK, Wolfe MM, Rothstein RI, Wo JM, Corley DA, Patti MG, Antignano LV, Goff JS, Edmundowicz SA, Castell DO, Rabine JC, Kim MS, Utley DS. The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial. Gastrointest Endosc. 2002 Feb;55(2):149-56.
  6. Yan C1, Liang WT1, Wang ZG1, Hu ZW1, Wu JM1, Zhang C1, Chen MP1. Comparison of Stretta procedure and toupet fundoplication for gastroesophageal reflux disease-related extra-esophageal symptoms. World J Gastroenterol. 2015 Dec 7;21(45):12882-7.
  7. Noar M1, Squires P, Noar E, Lee M. Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later. Surg Endosc. 2014 Aug;28(8):2323-33. doi: 10.1007/s00464-014-3461-6. Epub 2014 Feb 22.
  8. Hu ZW1, Wang ZG2, Zhang Y1, Wu JM1, Liang WT3, Yang Y1, Tian SR1, Wang AE4. A preliminary investigation of anti-reflux intervention for gastroesophageal reflux related childhood-to-adult persistent asthma. Ann Surg Innov Res. 2014 Jun 20;8:3. doi: 10.1186/1750-1164-8-3. eCollection 2014.
  9. McClusky DA 3rd1, Khaitan L, Swafford VA, Smith CD. Radiofrequency energy delivery to the lower esophageal sphincter (Stretta procedure) in patients with recurrent reflux after antireflux surgery: can surgery be avoided? Surg Endosc. 2007 Jul;21(7):1207-11. Epub 2007 Feb 17.
  10. Mattar SG1, Qureshi F, Taylor D, Schauer PR. Treatment of refractory gastroesophageal reflux disease with radiofrequency energy (Stretta) in patients after Roux-en-Y gastric bypass. Surg Endosc. 2006 Jun;20(6):850-4. Epub 2006 May 12.
  11. Liu DC1, Somme S, Mavrelis PG, Hurwich D, Statter MB, Teitelbaum DH, Zimmermann BT, Jackson CC, Dye C. Stretta as the initial antireflux procedure in children. J Pediatr Surg. 2005 Jan;40(1):148-51; discussion 151-2.
  12. Islam S1, Geiger JD, Coran AG, Teitelbaum DH. Use of radiofrequency ablation of the lower esophageal sphincter to treat recurrent gastroesophageal reflux disease. J Pediatr Surg. 2004 Mar;39(3):282-6; discussion 282-6.
  13. Liang WT, Wang ZG, Wang F, Yang Y, Hu ZW, Liu JJ, Zhu GC, Zhang C, Wu JM1. Long-term outcomes of patients with refractory gastroesophageal reflux disease following a minimally invasive endoscopic procedure: a prospective observational study. BMC Gastroenterol. 2014 Oct 10;14:178. doi: 10.1186/1471-230X-14-178.
  14. Dughera L1, Rotondano G2, De Cento M3, Cassolino P4, Cisarò F5. Durability of Stretta Radiofrequency Treatment for GERD: Results of an 8-Year Follow-Up. Gastroenterol Res Pract. 2014;2014:531907. doi: 10.1155/2014/531907. Epub 2014 May 18.
  15. Dundon JM1, Davis SS, Hazey JW, Narula V, Muscarella P, Melvin WS. Radiofrequency energy delivery to the lower esophageal sphincter (Stretta procedure) does not provide long-term symptom control. Surg Innov. 2008 Dec;15(4):297-301. doi: 10.1177/1553350608324508. Epub 2008 Sep 30.
  16. Reymunde A1, Santiago N. Long-term results of radiofrequency energy delivery for the treatment of GERD: sustained improvements in symptoms, quality of life, and drug use at 4-year follow-up. Gastrointest Endosc. 2007 Mar;65(3):361-6.
  17. Torquati A1, Houston HL, Kaiser J, Holzman MD, Richards WO. Long-term follow-up study of the Stretta procedure for the treatment of gastroesophageal reflux disease. Surg Endosc. 2004 Oct;18(10):1475-9. Epub 2004 Jul 22.
  18. Lipka S, Kumar A, Richter JE. No evidence for efficacy of radiofrequency ablation for the treatment of gastroesophageal reflux disease: as systematic review and meta-analysis. Clin Gastroenterol Hepatol 2015 June;12(6):1058-67.
  19. Funk LM1, Zhang JY2, Drosdeck JM2, Melvin WS2, Walker JP2, Perry KA2. Long-term cost-effectiveness of medical, endoscopic and surgical management of gastroesophageal reflux disease. Surgery. 2015 Jan;157(1):126-36. doi: 10.1016/j.surg.2014.05.027. Epub 2014 Sep 26.
  20. Fass R, Cahn F, Scotti DJ, Gregory DA. Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease. Surg Endo. In press.
  21. Corley DA, Katz P, Wo JM, et al. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology 2003; 125:668–676.
  22. Shrier I, Boivin JF, Steele RJ, et al. Should meta-analyses of interventions include observational studies in addition to randomized controlled trials? A critical examination of underlying principles. Am J Epidemiol 2007;166(10):1203-1209.
  23. Liang WT, Yan C, Wang ZG, et al. Early and midterm outcome after laparoscopic fundoplication and a minimally invasive endoscopic procedure in patients with gastroesophageal reflux disease prospective observational study. J Laparoendosc Adv Surg Tech A 2015;25(8):657-61.
  24. Richards WO, Scholz S, Khaitan L, Sharp KW, Holzman MD. Initial experience with the stretta procedure for the treatment of gastroesophageal reflux disease. J Laparoendosc Adv Surg Tech A. 2001 Oct;11(5):267-73.
  25. Triadafilopoulos G. Stretta: A valuable endoscopic treatment modality for gastroesophageal reflux disease. World J Gastroenterol. 2014 Jun 28; 20(24): 7730–7738.
  26. Auyang ED, Carter P, Rauth T, Fanelli RD. SAGES clinical spotlight review: endoluminal treatments for gastroesophageal reflux disease (GERD). Surg Endosc. 2013 Aug;27(8):2658-72.

Figure 1. Transoral Incisionless Fundoplication (TIF)

  • TIF 1 procedure with gastrogastric plications placed at the level of the Z-line
  • TIF 2 technique creates an esophagogastric fundoplication proximal to the Z-line

Bell & Cadiere. Transoral rotational esophagogastric fundoplication: Technical, anatomical and safety considerations. Surgical Endoscopy 2010

Figure 2. Stretta System

 

This document was prepared and revised by Jonathan Pearl MD, Eric Pauli MD, Brian Dunkin MD, Dimitrios Stefanidis MD, and the SAGES Guidelines Committee

This document was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in May 2017.

This is a revision of SAGES publication #CSR 1 printed Feb 2013, revised Mar 2017 and May 2017.

For more information please contact:

SOCIETY OF AMERICAN GASTROINTESTINAL ENDOSCOPIC SURGEONS (SAGES)
11300 West Olympic Blvd., Suite 600
Los Angeles, CA 90064
Tel:
(310) 437-0544
Fax:
(310) 437-0585
Email:
publications@sages.org

Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.

Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.