- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04464135
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
Status
Unknown
Conditions
Intervention / Treatment
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:
- Xiaojun Huang, MD
- Phone Number: +8609318942279
- Email: haungxj62@163.com
-
-
Guangdong
-
Shenzhen, Guangdong, China, 510000
- Recruiting
- Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University
-
Contact:
- Xiaoying Zhang, MD
- Phone Number: +8613116950266
- Email: 13116950266@163.com
-
-
Henan
-
Kaifeng, Henan, China, 475000
- Recruiting
- Department of Gastroenterology, Huaihe Hospital of Henan University
-
Contact:
- Jianghai Zhao, MD
- Phone Number: +8615191903630
- Email: 493109907@qq.com
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710005
- Recruiting
- Department of gastroenterology, Shaanxi Second People's Hospital
-
Contact:
- Limei Wang, MD
- Phone Number: +8615291680602
- Email: 15291680602@163.com
-
-
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.
General Publications
- Shibagaki K, Amano Y, Ishimura N, Yuki T, Taniguchi H, Fujita H, Kobayashi K, Kinoshita Y. Magnification endoscopy with acetic acid enhancement and a narrow-band imaging system for pit pattern diagnosis of colorectal neoplasms. J Clin Gastroenterol. 2015 Apr;49(4):306-12. doi: 10.1097/MCG.0000000000000148.
- Jia H, Pan Y, Guo X, Zhao L, Wang X, Zhang L, Dong T, Luo H, Ge Z, Liu J, Hao J, Yao P, Zhang Y, Ren H, Zhou W, Guo Y, Zhang W, Chen X, Sun D, Yang X, Kang X, Liu N, Liu Z, Leung F, Wu K, Fan D. Water Exchange Method Significantly Improves Adenoma Detection Rate: A Multicenter, Randomized Controlled Trial. Am J Gastroenterol. 2017 Apr;112(4):568-576. doi: 10.1038/ajg.2016.501. Epub 2016 Dec 6.
- Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
- Desai M, Sanchez-Yague A, Choudhary A, Pervez A, Gupta N, Vennalaganti P, Vennelaganti S, Fugazza A, Repici A, Hassan C, Sharma P. Impact of cap-assisted colonoscopy on detection of proximal colon adenomas: systematic review and meta-analysis. Gastrointest Endosc. 2017 Aug;86(2):274-281.e3. doi: 10.1016/j.gie.2017.03.1524. Epub 2017 Mar 29.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20200706-3
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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