Retroview™ Colonoscope and Lesion Detection Rate

NCT03155165 | Completed DMC

• 1 other identifier: DEC-19-2016
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is considered the gold standard for colorectal polyp and cancer detection. However, even meticulous colonoscopy substantial numbers of colorectal polyps may be missed and carcinomas may not be prevented. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas, with the higher miss rates noted for smaller polyps. The lesions missing rate depends on several factors 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, a poor bowel preparation and inadequate endoscopy technique, particularly rapid colonoscope withdrawal. Using the commonly available 140º angle of view colonoscope, approximately 13% of the colonic surface is unseen. The incorporation of colonoscopes with a 170-degree wide angled could not improve adenoma detection rate. The introduction of high definition (HD) colonoscopes and visual image enhancement technologies as narrow band imaging (NBI, Olympus America, Center Valley, PA), i-SCAN™ (PENTAX of America, Montvale, NJ) and Fuji Intelligent Chromo-Endoscopy (FICE™, Fujinon Endoscopy, Wayne, NJ) have improved the lesion characterization, but several studies proved no increase in adenoma detection rates. The Third Eye Retroscope (Avantis Medical Systems, Sunnyvale, CA) is a disposable retrograde viewing device advanced via the accessory channel of a standard colonoscope. Allows retrograde views behind colonic folds and flexures simultaneously with the forward view of the colon. Although it was shown an increase in adenoma detection rate by 11%-25%, it has many disadvantages. It requires a separate processor and the device is disposable making the cost bigger. Occupies the working channel of the colonoscope which limits the ability to suction. If a polyp is seen the viewing device has to be removed in order to perform the polypectomy. The optic is not high definition and finally, the endoscopist has to get used to visualizing and processing two simultaneous video streams from the colonoscope and from the retroscope device.

Conditions

Colonic Neoplasms

Keywords

Colonoscopy, Retroview™ colonoscope, retrofex colonoscopy

Outcome Measures

Primary Outcomes (2)

• Polyp detection rate with the standard colonoscope and Retroview™ scope.

  Polyps found with standard colonoscope / total of polys found X 100; polyps found with Retroview™ scope / total of polys found X 100; The total of polyps found will be determinated by the combination of both technics (standard colonoscope and Retroview™ scope)

  8 month

• Adenoma detection rate with the standard colonoscope and Retroview™ scope.

  Adenomas found with standard colonoscope / total of adenomas found X 100; adenomas found with Retroview™ scope / total of adenomas found X 100. The total of adenomas found will be determinated by the combination of both technics (standard colonoscope and Retroview™ scope)

  8 month

Secondary Outcomes (2)

• Lesion miss rate with the standard colonoscope and Retroview™ scope.

  8 month

• Number and size of lesions (adenomas and polyps) detected with the standard colonoscope and Retroview ™ scope.

  8 month

Study Arms (2)

Group A Retroview™ colonoscope

Patients that have a polyp already seen in a previous colonoscopy and the colonoscopy is indicated for polypectomy will be submitted to a Retroview™ colonoscope

Device: Retroview™ colonoscope

Group B Retroview™ colonoscope

The rest of colonoscopies indicated will be submitted to a Retroview™ colonoscope

Device: Retroview™ colonoscope

Interventions

Retroview™ colonoscope DEVICE

The colonoscopy will be performed twice, with 2 different scopes, in tandem, by 2 endoscopists trained on retroflex withdrawal. First a conventional HD colonoscope with I-Scan will be used following the standard withdrawal technique and then the second endoscopist blinded to the first colonoscopy results, will perform the second colonoscopy using the Retroview™ scope with a combining withdrawal (retroflexed + standard withdrawal). The endoscopist that will perform each colonoscopy will be chosen randomly. After the examination, the endoscopist will fill a questionnaire detailing each polyp / adenoma found including the size and location.

Group A Retroview™ colonoscope; Group B Retroview™ colonoscope

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the gastroenterology unit (IECED). All of the participants will have a clear colonoscopy indication. Group A will include patients that have a polyp already seen in a previous colonoscopy and the colonoscopy is indicated for polypectomy. Group B will include the rest of indicated colonoscopies. The distribution in groups A and B is with no intention to compeer the groups but in order to avoid a bias because the patients already have a known lesion.

You may qualify if:

• Patients that agree to participate in the study.
• Able to understand and provide written informed consent.
• Colonoscopy indication for colorectal neoplasia screening or polyp surveillance.
• Colonoscopy indication for polypectomy.
• Colonoscopy indication for diagnostic workup including anemia, abdominal pain, constipation, abnormal imaging.

You may not qualify if:

• Age under 18 and over 80 years' old.
• Pregnancy
• Patients with heart disease, kidney, liver or severe metabolic disorder, who cannot tolerate sedation.
• Severe uncontrolled coagulopathy.
• Patients with difficulty understanding instructions of bowel preparation.
• Prior history of colon resection.
• Patients with an ileostomy or a colostomy.
• Abdomen or pelvis radiation therapy.
• Known inflammatory bowel disease, polyposis syndrome or acute diverticulitis.
• Suspected colonic obstruction or history of previous obstruction.
• Gastrointestinal bleeding.
• Lack of acceptance by the patient.
• Bowel preparation will be evaluated using the Boston Bowel Preparation Scale. Patients with \< 2 points in at least one of the three segments of the colon (rectum plus left-side colon, transverse colon plus left and right flexure, right-side colon) will be excluded from statistical analysis as well as those who after the beginning of the colonoscopy, had to be aborted because of an inability to reach the cecum by unfavorable anatomy or impassable tumors / stenosis.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Ecuadorian Institute of Digestive Diseases, Omnihospital

Guayaquil, Guayas, 090505, Ecuador

Location

Related Publications (23)

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• Waye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, Rex DK. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos). Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16.

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• Leufkens AM, DeMarco DC, Rastogi A, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, Siersema PD; Third Eye Retroscope Randomized Clinical Evaluation [TERRACE] Study Group. Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: the TERRACE study. Gastrointest Endosc. 2011 Mar;73(3):480-9. doi: 10.1016/j.gie.2010.09.004. Epub 2010 Nov 10.

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Histology sample of polypectomies

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Carlos A Robles-medranda, MD

  Ecuadorian Institute of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: May 16, 2017
• Study Start: May 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: August 31, 2017
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

EC (1)