Serrated Lesions Detection With Endocuff-assisted Colonoscopy
Primary Purpose
Serrated Lesion, Adenoma, Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Endocuff colonoscopy
control
Sponsored by
About this trial
This is an interventional treatment trial for Serrated Lesion focused on measuring Serrated Lesion, Endocuff, Detection
Eligibility Criteria
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
Sites / Locations
- Hospital Beatriz Ângelo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Endocuff colonoscopy
Conventional colonoscopy
Arm Description
Colonoscopy performed with Endocuff
Colonoscopy performed without any device
Outcomes
Primary Outcome Measures
Average number of serrated lesions ≥ 10 mm detected per colonoscopy
Average number of serrated lesions ≥ 10 mm detected per colonoscopy
Secondary Outcome Measures
Serrated lesions detection rate
Number of patients with at least one serrated lesion/total number of participants
Average number of serrated lesions < 10 mm detected per colonoscopy
Average number of serrated lesions < 10 mm detected per colonoscopy
Average number of adenomas detected per colonoscopy
Average number of adenomas detected per colonoscopy
Adenoma detection rate
Number of patients with at least one adenoma/total number of participants
Adenocarcinoma detection rate
Number of patients with at least one adenocarcinoma/total number of participants
Cecal intubation rate
Proportion of colonoscopies with cecal intubation x100
Cecal incubation time
time from the rectum to cecum in minutes
Withdrawal time
time from the cecum to the rectum in minutes
Incidence of procedure related adverse events
Number of adverse events
Full Information
NCT ID
NCT03856957
First Posted
February 26, 2019
Last Updated
February 14, 2021
Sponsor
Hospital Beatriz Ângelo
1. Study Identification
Unique Protocol Identification Number
NCT03856957
Brief Title
Serrated Lesions Detection With Endocuff-assisted Colonoscopy
Official Title
Serrated Lesions Detection With Endocuff-assisted Colonoscopy - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Beatriz Ângelo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serrated Lesion, Adenoma, Colorectal Cancer
Keywords
Serrated Lesion, Endocuff, Detection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
257 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endocuff colonoscopy
Arm Type
Experimental
Arm Description
Colonoscopy performed with Endocuff
Arm Title
Conventional colonoscopy
Arm Type
Placebo Comparator
Arm Description
Colonoscopy performed without any device
Intervention Type
Device
Intervention Name(s)
Endocuff colonoscopy
Intervention Description
Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).
Intervention Type
Device
Intervention Name(s)
control
Intervention Description
colonoscopy without endocuff
Primary Outcome Measure Information:
Title
Average number of serrated lesions ≥ 10 mm detected per colonoscopy
Description
Average number of serrated lesions ≥ 10 mm detected per colonoscopy
Time Frame
immediate
Secondary Outcome Measure Information:
Title
Serrated lesions detection rate
Description
Number of patients with at least one serrated lesion/total number of participants
Time Frame
immediate
Title
Average number of serrated lesions < 10 mm detected per colonoscopy
Description
Average number of serrated lesions < 10 mm detected per colonoscopy
Time Frame
immediate
Title
Average number of adenomas detected per colonoscopy
Description
Average number of adenomas detected per colonoscopy
Time Frame
immediate
Title
Adenoma detection rate
Description
Number of patients with at least one adenoma/total number of participants
Time Frame
immediate
Title
Adenocarcinoma detection rate
Description
Number of patients with at least one adenocarcinoma/total number of participants
Time Frame
immediate
Title
Cecal intubation rate
Description
Proportion of colonoscopies with cecal intubation x100
Time Frame
immediate
Title
Cecal incubation time
Description
time from the rectum to cecum in minutes
Time Frame
immediate
Title
Withdrawal time
Description
time from the cecum to the rectum in minutes
Time Frame
immediate
Title
Incidence of procedure related adverse events
Description
Number of adverse events
Time Frame
immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Beatriz Ângelo
City
Lisbon
State/Province
Loures
ZIP/Postal Code
2674-514
Country
Portugal
12. IPD Sharing Statement
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Serrated Lesions Detection With Endocuff-assisted Colonoscopy
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