NCT03901651

Combined Forward and Retroflexion Withdrawal in the Detection of Polyps and Adenoma During Colonoscopy

Completed NA Last updated 2 June 2021

What this trial tests

NA trial testing Colonoscopy with Retroview scope combing forward and retroflexed withdrawal technique in Colonic Polyp in 203 participants. Completed in 1 January 2021.

Timeline

2 January 2019

Primary endpoint
1 December 2020

1 January 2021

Quick facts

Lead sponsor	Instituto Ecuatoriano de Enfermedades Digestivas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	203
Start date	2 January 2019
Primary completion	1 December 2020
Estimated completion	1 January 2021
Sites	1 location across Ecuador

Drugs / interventions tested

• Colonoscopy with Retroview scope combing forward and retroflexed withdrawal technique
• Colonoscopy with standard colonoscope and forward withdrawal technique

Conditions studied

• Colonic Polyp — all drugs for Colonic Polyp →
• Colonic Neoplasms — all drugs for Colonic Neoplasms →
• Colonic Adenoma — all drugs for Colonic Adenoma →

Sponsor

Instituto Ecuatoriano de Enfermedades Digestivas — full company profile →

Who can join

Adults 45 to 80, any sex, with Colonic Polyp or Colonic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Colonoscopy is the standard of care for the detection of colorectal polyps and adenoma, and colorectal cancer detection. Despite a meticulous evaluation of the colonic mucosa during colonoscopy, a substantial number of colorectal polyps might be missed and colorectal cancer might not be prevented.

Previous studies described a 12-28% of miss-rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas, with a higher miss rate noted for smaller polyps. The lesion missing rate depends on several factors, such as the location on difficult areas to be evaluated with conventional colonoscopes (the proximal side of the ileocecal valve, haustral folds, flexures or rectal valves), a flat shape, an inadequate bowel preparation and inadequate endoscopy technique, a time-limited colonoscope withdrawal.

If the standard 140º angle of view colonoscope is used approximately 13% of the colonic surface is unevaluated. The incorporation of colonoscopes with a 170-degree wide angled could improve adenoma detection rate.

The introduction of high definition (HD) colonoscopes and visual image enhancement technologies, such as narrow band imaging (NBI, Olympus America, Center Valley, PA), I-SCAN™ (Pentax Medical, Montvale, NJ) and Fuji Intelligent Chromo-Endoscopy (FICE™, Fujinon Endoscopy, Wayne, NJ) have improved the lesion characterization; however, several studies have failed to prove an increase in the adenoma detection rates.

The Third Eye Retroscope (Avantis Medical Systems, Sunnyvale, CA) is a disposable retrograde viewing device advanced through the accessory channel of a standard colonoscope. It allows retrograde viewing behind colonic folds and flexures simultaneously with the forward view of the colon. Although it shows an increase in the adenoma detection rate by 11%-25%, it has many disadvantages. First, it requires a separate processor and the device is disposable, increasing the cost of the procedure. Second, it occupies the working channel of the colonoscope, limiting the ability to suction. Third, if a polyp is detected, the viewing device has to be removed in order to perform the polypectomy. Fourth, the optic is not high definition and finally, the endoscopist has to get used to visualizing and processing two simultaneous video streams from the colonoscopy and from the retroscope device.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.