Serrated Lesions Detection With Endocuff-assisted Colonoscopy

Overview

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.

Full Title of Study: “Serrated Lesions Detection With Endocuff-assisted Colonoscopy – A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 30, 2019

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Endocuff colonoscopy
    • Colonoscopy performed with Endocuff
  • Placebo Comparator: Conventional colonoscopy
    • Colonoscopy performed without any device

Clinical Trial Outcome Measures

Primary Measures

  • Average number of serrated lesions ≥ 10 mm detected per colonoscopy
    • Time Frame: immediate
    • Average number of serrated lesions ≥ 10 mm detected per colonoscopy

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospital Beatriz Ângelo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alexandre Ferreira, Dr – Hospital Beatriz Ângelo
  • Overall Contact(s)
    • Maria Pia Costa Santos, MD, +351962527073, mariapiacostasantos@gmail.com

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