Serrated Lesions Detection With Endocuff-assisted Colonoscopy

Serrated Lesions Detection With Endocuff-assisted Colonoscopy - A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Adenoma; Serrated Lesion
• Intervention / Treatment: Device: Endocuff colonoscopy; Device: control

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Loures
    • Lisbon, Loures, Portugal, 2674-514
      • Hospital Beatriz Ângelo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Outpatients undergoing elective colonoscopies

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Endocuff colonoscopy; Colonoscopy performed with Endocuff	Device: Endocuff colonoscopy; Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).
PLACEBO_COMPARATOR: Conventional colonoscopy; Colonoscopy performed without any device	Device: control; colonoscopy without endocuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of serrated lesions ≥ 10 mm detected per colonoscopy	Average number of serrated lesions ≥ 10 mm detected per colonoscopy	immediate

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Beatriz Ângelo

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2018
• Primary Completion (ACTUAL): March 30, 2019
• Study Completion (ACTUAL): July 1, 2019

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (ACTUAL): February 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 14, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Detection; Endocuff; Serrated Lesion
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 0304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No