Skip to main content
OpenTrials
Completed

NCT Number: NCT03856957

Serrated Lesions Detection With Endocuff-assisted Colonoscopy

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endocuff colonoscopy

Device

Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).

Control

Device

colonoscopy without endocuff

Primary outcomes

  1. 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

  1. Serrated lesions detection rate

    Time frame: immediate

    Number of patients with at least one serrated lesion/total number of participants

  2. Average number of serrated lesions < 10 mm detected per colonoscopy

    Time frame: immediate

    Average number of serrated lesions < 10 mm detected per colonoscopy

  3. Average number of adenomas detected per colonoscopy

    Time frame: immediate

    Average number of adenomas detected per colonoscopy

  4. Adenoma detection rate

    Time frame: immediate

    Number of patients with at least one adenoma/total number of participants

  5. Adenocarcinoma detection rate

    Time frame: immediate

    Number of patients with at least one adenocarcinoma/total number of participants

  6. Cecal intubation rate

    Time frame: immediate

    Proportion of colonoscopies with cecal intubation x100

  7. Cecal incubation time

    Time frame: immediate

    time from the rectum to cecum in minutes

  8. Withdrawal time

    Time frame: immediate

    time from the cecum to the rectum in minutes

  9. Incidence of procedure related adverse events

    Time frame: immediate

    Number of adverse events

Sponsors and collaborators

Lead sponsor

Hospital Beatriz Ângelo

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2019
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.