Serrated Lesions Detection With Endocuff-assisted Colonoscopy

Not Applicable

Completed

• Conditions: Adenoma; Colorectal Cancer; Serrated Lesion
• Interventions: Device: control; Device: Endocuff colonoscopy

• Registration Number: NCT03856957
• Lead Sponsor: Hospital Beatriz Ângelo

Brief Summary

Colorectal cancer (CRC) is a leading cause of morbidity and mortality worldwide, especially in Western countries. CRC is currently considered a preventable disease and screening has been endorsed by several societies, since it has been shown that screening and surveillance are effective in reducing both CRC incidence and mortality. However, recently, concern has risen regarding colonoscopy effectiveness, especially in the right colon. The most accepted explanation for this effectiveness variability is attributed to sessile serrated lesions (SSL), which are more frequent in the proximal colon, more difficult to detect because of their flat morphology and associated with interval CRC, which is the occurrence of CRC after screening colonoscopy and before the next scheduled procedure. Several techniques are emerging to increase the sensitivity of colonoscopy for pre-cancerous lesions, especially adenomas. Recently an endoscopic cap, the Endocuff, was developed to improve adenoma detection. Several studies demonstrated improved adenoma detection with Endocuff-assisted colonoscopy when compared with conventional colonoscopy. Still, the available data for its' role in detecting SSL is very limited. The aim of this randomized controlled trial is to evaluate the effectiveness of Endocuff-assisted colonoscopy in detection of colorectal SSL.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-11
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-27
• Primary Completion: 2019-03-30
• Study Completion: 2019-07-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-14
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

• Outpatients undergoing elective colonoscopies

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Exclusion Criteria

• Known polyposis syndromes
• Personal colorectal cancer history
• Previous colorectal surgery
• Severe diverticulosis
• Colonic stricture
• Inflammatory bowel disease
• Primary sclerosing cholangitis
• Pregnancy and breastfeeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional colonoscopy	control	Colonoscopy performed without any device
Endocuff colonoscopy	Endocuff colonoscopy	Colonoscopy performed with Endocuff

Primary Outcome Measures

Name	Time	Method
Average number of serrated lesions ≥ 10 mm detected per colonoscopy	immediate	Average number of serrated lesions ≥ 10 mm detected per colonoscopy

Secondary Outcome Measures

Name	Time	Method
Cecal intubation rate	immediate	Proportion of colonoscopies with cecal intubation x100
Incidence of procedure related adverse events	immediate	Number of adverse events
Adenoma detection rate	immediate	Number of patients with at least one adenoma/total number of participants
Adenocarcinoma detection rate	immediate	Number of patients with at least one adenocarcinoma/total number of participants
Cecal incubation time	immediate	time from the rectum to cecum in minutes
Withdrawal time	immediate	time from the cecum to the rectum in minutes
Average number of adenomas detected per colonoscopy	immediate	Average number of adenomas detected per colonoscopy
Average number of serrated lesions < 10 mm detected per colonoscopy	immediate	Average number of serrated lesions \< 10 mm detected per colonoscopy
Serrated lesions detection rate	immediate	Number of patients with at least one serrated lesion/total number of participants

Trial Locations

Locations (1)

Hospital Beatriz Ângelo; 🇵🇹 Lisbon, Loures, Portugal