Serrated Lesions Detection With Endocuff-assisted Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856957
• Other study ID #: 0304
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: February 2021
• Source: Hospital Beatriz Ângelo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: July 1, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Serrated Lesion

Intervention

Device:
• Endocuff colonoscopy
Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).
• control
colonoscopy without endocuff

Locations

Country	Name	City	State
Portugal	Hospital Beatriz Ângelo	Lisbon	Loures

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Beatriz Ângelo

Country where clinical trial is conducted

Portugal, 

Outcome

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