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

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ClinicalTrials.gov Identifier: NCT03566615
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : February 2, 2022
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Felix W. Leung, VA Greater Los Angeles Healthcare System

Study Description
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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
Colonoscopy Polyp of Colon Device: CAP-straight Device: CAP-daisy Other: water Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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)

  3. Cecal intubation time [ Time Frame: 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) [ Time Frame: 2 hours: Data collected during colonoscopy procedure ]
    Patient satisfaction

  5. Willing to repeat [ Time Frame: 2 hours: Data collected during colonoscopy procedure ]
    Visual analogue scale (0=not willing, 10=willing)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566615


Contacts
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Contact: Nora Jamgotchian, MS 818-895-9426 Nora.Jamgotchian@va.gov
Contact: Felix W Leung, MD 818-891-7711 ext 32520 Felix.Leung@va.gov

Locations
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United States, California
Sacramento VAMC, VA Northern California Healthcare System Recruiting
Mather, California, United States, 95655-4200
Contact: Andrew Yen, MD       andrew.yen3@va.gov   
Contact: Joseph W Leung, MD       Joseph.Leung@va.gov   
Veterans Affairs Palo Alto Healthcare System Recruiting
Palo Alto, California, United States, 94550
Contact: Shai Friedland, MD       shai_friedland@yahoo.com   
Contact: Ramsey Cheung, MD       rcheung@stanford.edu   
China
Xijing Hospital of Digestive Diseases Recruiting
Xian, China, 710032
Contact: Yanglin Pan, MD       panyanglin@gmail.com   
Italy
St. Barbara Hospital Recruiting
Iglesias, Italy
Contact: SErgio Cadoni, MD       cadonisergio@gmail.com   
Taiwan
Dalin Tzu Chi General Hospital Recruiting
Chiayi City, Taiwan, 622
Contact: Yu-Hsi Hsieh, MD       hsieh.yuhsi@msa.hinet.net   
Hualien Tzu Chi Hospital Recruiting
Hualien City, Taiwan
Contact: Chi-Tan Hu, MD       chitan.hu@msa.hinet.net   
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
University of California, Los Angeles
Investigators
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Principal Investigator: Felix W Leung, MD VA Greater Los Angeles Healthcare System
More Information
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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: June 25, 2018    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Felix W. Leung, VA Greater Los Angeles Healthcare System:
colonoscopy
adenoma detection rate
caps
Additional relevant MeSH terms:
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Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps