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

Sponsor
VA Greater Los Angeles Healthcare System (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT03566615
Collaborator
University of California, Los Angeles (Other)
1,630
7
3
54
232.9
4.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CAP-straight
  • Device: CAP-daisy
  • Other: water
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1630 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Does the Addition of a Cap Improve the Adenoma Detection Rate During Water Exchange Colonoscopy
Actual Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

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.

Other: water
using water instead of traditional air insufflation to help insertion

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.

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.

Other: water
using water instead of traditional air insufflation to help insertion

Outcome Measures

Primary Outcome Measures

  1. Adenoma detection rate [2 years]

    The proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas, or polyps, detected.

Secondary Outcome Measures

  1. Cecal intubation [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. Boston bowel preparation score [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)

  3. Cecal intubation time [2 hours: Data collected during colonoscopy procedure]

    Total time from insertion into the anus to arrival in the cecum

  4. Visual analogue scale (0=not satisfied, 10=very satisfied) [2 hours: Data collected during colonoscopy procedure]

    Patient satisfaction

  5. Willing to repeat [2 hours: Data collected during colonoscopy procedure]

    Visual analogue scale (0=not willing, 10=willing)

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sacramento VAMC, VA Northern California Healthcare System Mather California United States 95655-4200
2 Veterans Affairs Palo Alto Healthcare System Palo Alto California United States 94550
3 Xijing Hospital of Digestive Diseases Xian China 710032
4 St. Barbara Hospital Iglesias Italy
5 Dalin Tzu Chi General Hospital Chiayi City Taiwan 622
6 Hualien Tzu Chi Hospital Hualien City Taiwan
7 Evergreen General Hospital Taipei Taiwan

Sponsors and Collaborators

  • VA Greater Los Angeles Healthcare System
  • University of California, Los Angeles

Investigators

  • Principal Investigator: Felix W Leung, MD, VA Greater Los Angeles Healthcare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Felix W. Leung, Site PI and Director of Study, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier:
NCT03566615
Other Study ID Numbers:
  • ASGE 2016 International Award
First Posted:
Jun 25, 2018
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Felix W. Leung, Site PI and Director of Study, VA Greater Los Angeles Healthcare System
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022