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Clinical Trials/NCT03856957
NCT03856957CompletedNot Applicable

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

Hospital Beatriz Ângelo2 sites in 1 country257 target enrollmentStarted: June 11, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
257
Locations
2
Primary Endpoint
Average number of serrated lesions ≥ 10 mm detected per colonoscopy

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Average number of serrated lesions ≥ 10 mm detected per colonoscopy

Time Frame: immediate

Average number of serrated lesions ≥ 10 mm detected per colonoscopy

Secondary Outcomes

  • Average number of adenomas detected per colonoscopy(immediate)
  • Cecal intubation rate(immediate)
  • Withdrawal time(immediate)
  • Incidence of procedure related adverse events(immediate)
  • Average number of serrated lesions < 10 mm detected per colonoscopy(immediate)
  • Serrated lesions detection rate(immediate)
  • Adenoma detection rate(immediate)
  • Adenocarcinoma detection rate(immediate)
  • Cecal incubation time(immediate)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alexandre Ferreira

Dr

Hospital Beatriz Ângelo

Study Sites (2)

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