Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Colonoscopy

July 7, 2020 updated by: Yanglin Pan, Air Force Military Medical University, China

Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Screening and Surveillance Colonoscopy: a Multi-centered, Randomized Controlled Study.

Our previous study (Am. J. Gastroenterol. 2017 04;112(4)) showed that water exchange (WE) colonoscopy was able to increase the detection of flat adenomas as well as overall ADR. We hypothesized that WE based whole-colon acetic acid(AA) staining might be useful to improve the detection of flat lesions compared with WE alone.

Study Overview

Detailed Description

Water exchange colonoscopy was performed as described previously (Am. J. Gastroenterol. 2017 04;112(4)). Patients were randomly allocated to WE group or WE+AA group. In WE+AA group, water containing 1% of AA was used during insertion of colonoscopy instead of water alone. A bottle of 20ml pure AA was placed abutting the water pump, which make it possible to keep patients blinded to group allocation. Endoscopist using a high-definition wide-angle Olympus or Fujinum colonoscope performed all of the colonoscopies, with a withdrawal time of at least 6 min. The observation was initially performed without the assistance of cap or the use of magnification or electronic staining (NBI, BLI, LCI or AFI et al.). Scopolamine butylbromide or glucogon was not routinely administrated.

Study Type

Interventional

Enrollment (Anticipated)

300

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 Locations

    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Recruiting
        • Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China, 510000
        • Recruiting
        • Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University
        • Contact:
    • Henan
      • Kaifeng, Henan, China, 475000
        • Recruiting
        • Department of Gastroenterology, Huaihe Hospital of Henan University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710005
        • Recruiting
        • Department of gastroenterology, Shaanxi Second People's Hospital
        • 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

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 40-70
  • Undergoing colonoscopy after standard bowel preparation

Exclusion Criteria:

  • Known familial polyposis
  • Small amount of feces or semi-solid stool in last rectal effluent
  • Inflammatory Bowel Disease
  • Lactated or pregnant women
  • Unable to provide informed content

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: WE+AA group
Water containing 1% of AA was used during insertion of colonoscopy using water exchange method.
The water exchange colonoscopy is used during insertion procedure, in which the water contains 1% acetic acid, and the liquid is absorbed during the withdrawal process for observation.
ACTIVE_COMPARATOR: WE group
Water exchange colonoscopy was used for standard screening or surveillance colonoscopy.
The water exchange colonoscopy is used during insertion procedure, and the liquid is absorbed during the withdrawal process for observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of flat polyps per patient
Time Frame: 9 months
average numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall ADR
Time Frame: 9 months
Adenoma detection rate, defined as the proportion of subjects with at least one adenoma of any size, in each group.
9 months
Advanced ADR
Time Frame: 9 months
Advanced adenoma detection rate. Advanced adenoma: any with 3 or more adenomas of any size, 1 or more large adenomas 1 cm, or 1 or more adenomas with villous architecture or highgrade dysplasia.
9 months
SSA/P detection rate
Time Frame: 9 months
SSA/P detection rate, defined as the proportion of subjects with at least one sessile serrated adenoma/polyp (SSA/P) of any size, in each group.
9 months
Flat neoplasms located in proximal colon
Time Frame: 9 months
Low-grade adenoma, adenoma with villous components, high-grade adenoma, noninvasive carcinoma, and invasive carcinoma in proximal colon
9 months
Adverse events
Time Frame: 9 months
the rate of bleeding and perforation during colonoscopy procedure and abdominal pain, diarrhea, hematochezia and change of defecation habit Within one week.
9 months

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (ANTICIPATED)

July 15, 2020

Primary Completion (ANTICIPATED)

April 15, 2021

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (ACTUAL)

July 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

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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