A Novel Add-On Device Improves Stabilisation and Visualisation during Colonoscopy.

S K Sharma1, A Datta1, A Nguyen1, C D Dillon1, L Lefebvre1, G Silberhumer2, J F Cornhill1, J W Milsom1. 1Minimally Invasive New Technologies, Weill Cornell Medical College & New York Presbyterian Hospitaln, 2Medical University Vienna, Department of Surgery, Vienna, Austria

Introduction

Colonoscopy (CY) is the gold standard for detection and prevention of colorectal cancer (CRC), with an estimated fourteen million procedures performed annually in the USA alone.

Despite widespread use, CY has technical challenges including lack of stability relative to the intestinal wall (requiring repetitive adjustment or additional personnel to assist the endoscopist) and poor visualisation (requiring continuous gas insufflation with patient discomfort). Indeed, these technical difficulties may be major contributory factors to the significant number (up to 30%) of colonic polyps missed during CY.

Additionally, more complex CY procedures such as Endoscopic Submucosal Dissection (ESD) and Combined Endoscopic and Laparoscopic Surgery (CELS) are permitting avoidance of major surgery in many patients.

The Endoscopic Surgical Platform (ESP) was developed to overcome some challenges of conventional CY, facilitate advancement of surgical procedures into the endoscopic domain and improve patient outcomes. ESP is a novel double-balloon endoscopic add-on device that can be incorporated onto commercially available colonoscopes.

Aims

Assess ESP’s in-vitro capability during CY to:

  • Improve stability
  • Improve visualization

Methods

In this study, we used an Olympus pediatric colonoscope (PCF-H180AL), an ESP device, silicone colon model with 1 centimetre (cm) markers placed with indelible ink and Kyoto-Kagaku colonoscopic trainer. The student’s t-test was used to determine statistical significance unless otherwise stated.

The following variables were measured with and without ESP added onto the colonoscope:

Completion in reaching the Kyoto-Kagaku Model (KKM) ‘caecum’
Time to reach KKM ‘caecum’
Stability of CS tip upon applying a 5 centimetre (cm) longitudinal traction force to the CS externally
‘Mucosal’ surface area visualized
Insufflation time to distend colon to a level deemed clinically acceptable to the endoscopist

Results

There was no migration of the CS tip using ESP versus 60 cm without ESP upon longitudinal traction (p<0.0001). ESP use significantly increased the ‘mucosal’ surface area visualised to approximately 50cm2, from 34.6cm2 and 39cm2 (straight and flexure segment of intestine model respectively, p<0.0001). The time taken to reach a clinically acceptable level of visualisation was significantly reduced using the ESP device – 15.6 and 19.3 seconds versus 35 and 57 seconds (straight and flexure segment of intestine model respectively, p<0.0001). CS functionality was preserved in its entirety whilst using ESP.

Conclusions

The addition of the ESP device to commercially available colonoscopes significantly enhances it’s functionality, through improved visualisation and stability. This may have direct benefits in both current and future surgical applications of CY. Further in-vivo studies are required to expand on these promising results.

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