Does the Cap Increase the Finding of Polyps When Water Exchange Colonoscopy is Used (ASGE)

October 4, 2022 updated by: Felix W. Leung, VA Greater Los Angeles Healthcare System

Does the Addition of a Cap Improve the Adenoma Detection Rate During Water Exchange Colonoscopy

This is a study to compare two different, but normally, used methods of colonoscopy in patients that require a routine or repeat colonoscopy. There will be three arms in this study: WE water control, water plus Cap-1, and water plus Cap-2. The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air inserted into the colon. The study method will use a new accessory, a cap that will fit onto the end of the colonoscope plus water during the procedure. This study will also confirm if using the cap method with water is a better way of detecting polyps in the colon and possibly cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a multi-site, multi-national, unblinded investigators, prospective Random Control Trial (RCT). Randomization (WE, WE Cap-1, WE Cap-2) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two different methods with three arms (WE, WE Cap-1, WE Cap-2) to see which one is better at detecting adenomas.

Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and type of colonoscopy (screening or surveillance). Mode of sedation will include unsedated (China, US West Los Angeles VA), minimally sedated (Taiwan), on demand sedation (Italy, Czech Republic, US West Los Angeles VA), conscious sedation (US Sacramento VA and Palo Alto VA) or full sedation with propofol (Taiwan). Randomization (prepared by statistics consultant) will be carried out by the method of random permuted block design (based on computer generated random numbers) with variable block sizes of 3 and 6. Gender will be used as a stratification factor.

Control Method: One arm of the study will include sedated/unsedated colonoscopy with water (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.

Study method: The other two arms entail the addition of a simple commercially available accessory to the colonoscopy device: Cap -1 (Disposable Distal Attachment) or Cap-2, fitted to the colonoscope per manufacturer instruction. The two arms include sedated/unsedated colonoscopy with either a Cap-1 plus water or Cap-2 plus water.

Study Type

Interventional

Enrollment (Anticipated)

1630

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Xian, China, 710032
        • Recruiting
        • Xijing Hospital of Digestive Diseases
        • Contact:
  • Italy
      • Iglesias, Italy
        • Completed
        • St. Barbara Hospital
  • Taiwan
      • Chiayi City, Taiwan, 622
      • Hualien City, Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Evergreen General Hospital
        • Contact:
          • Cheng Chiliang, MD
  • United States
    • California
      • Mather, California, United States, 95655-4200
        • Recruiting
        • Sacramento VAMC, VA Northern California Healthcare System
      • Palo Alto, California, United States, 94550
        • Recruiting
        • Veterans Affairs Palo Alto Healthcare System
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female 50-75 yrs of age.
  2. Positive screening for Fecal Immunochemical Test (FIT) or Fecal Occult Blood Test (FOBT).
  3. Subjects willing to undergo routine screening and surveillance colonoscopy.

Exclusion Criteria:

  1. Patients who decline to provide informed consent.
  2. Patients known to have colonic obstruction, inflammatory bowel disease, or active GI bleeding requiring interventions.
  3. Patients know to have prior history of severe diverticulitis/diverticulosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Water
Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.
Other: water
using water instead of traditional air insufflation to help insertion
Experimental: CAP-straight
A straight transparent cap was fitted to the colonoscope per manufacturer instruction.Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.
Other: water
using water instead of traditional air insufflation to help insertion
Device: CAP-straight
This study is to detect any differences in the detection rate of adenomas using straight caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure.
Experimental: CAP-daisy

A daisy cap transparent cap was fitted to the colonoscope per manufacturer instruction.Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.

Note:

IRB Approval date for the use of Endocuff at St. Barbara Hospital, Iglesias (CA), Italy, was obtained on 3/8/2017.

IRB Approval date for the use of Endocuff at Evergreen General Hospital, Taipei, Taiwan, was obtained on 3/18/2021.
Other: water
using water instead of traditional air insufflation to help insertion
Device: CAP-daisy
This study is to detect any differences in the detection rate of adenomas using daisy caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: 2 years
The proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas, or polyps, detected.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cecal intubation
Time Frame: 2 hours: Data collected during colonoscopy procedure
Visualization of ileocecal valve/appendix orifice and the medial wall of the cecum with colonoscope tip touching floor of cecum
2 hours: Data collected during colonoscopy procedure
Boston bowel preparation score
Time Frame: 2 hours: Data collected during colonoscopy procedure
Three segments (Right, transverse, left colon), each with 0 to 3 (poor to excellent); total scores = sum (10 point scale)
2 hours: Data collected during colonoscopy procedure
Cecal intubation time
Time Frame: 2 hours: Data collected during colonoscopy procedure
Total time from insertion into the anus to arrival in the cecum
2 hours: Data collected during colonoscopy procedure
Visual analogue scale (0=not satisfied, 10=very satisfied)
Time Frame: 2 hours: Data collected during colonoscopy procedure
Patient satisfaction
2 hours: Data collected during colonoscopy procedure
Willing to repeat
Time Frame: 2 hours: Data collected during colonoscopy procedure
Visual analogue scale (0=not willing, 10=willing)
2 hours: Data collected during colonoscopy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Greater Los Angeles Healthcare System

Collaborators

University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASGE 2016 International Award

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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