Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Colonoscopy
1 other identifier
interventional
300
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2020
CompletedFirst Posted
Study publicly available on registry
July 9, 2020
CompletedStudy Start
First participant enrolled
July 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedJuly 9, 2020
July 1, 2020
9 months
July 7, 2020
July 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of flat polyps per patient
average numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient
9 months
Secondary Outcomes (5)
Overall ADR
9 months
Advanced ADR
9 months
SSA/P detection rate
9 months
Flat neoplasms located in proximal colon
9 months
Adverse events
9 months
Study Arms (2)
WE+AA group
EXPERIMENTALWater containing 1% of AA was used during insertion of colonoscopy using water exchange method.
WE group
ACTIVE COMPARATORWater exchange colonoscopy was used for standard screening or surveillance colonoscopy.
Interventions
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.
The water exchange colonoscopy is used during insertion procedure, and the liquid is absorbed during the withdrawal process for observation.
Eligibility Criteria
You may qualify if:
- Aged 40-70
- Undergoing colonoscopy after standard bowel preparation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University
Lanzhou, Gansu, 730030, China
Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 510000, China
Department of Gastroenterology, Huaihe Hospital of Henan University
Kaifeng, Henan, 475000, China
Department of Gastroenterology, Shaanxi Second People's Hospital
Xi'an, Shaanxi, 710005, China
Related Publications (4)
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.
PMID: 24804989BACKGROUNDJia 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.
PMID: 27922025RESULTZhao 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.
PMID: 30738046RESULTDesai 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.
PMID: 28365356RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Yanglin Pan, MD
Xijing Hospital of Digestive Diseases
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated professor
Study Record Dates
First Submitted
July 7, 2020
First Posted
July 9, 2020
Study Start
July 15, 2020
Primary Completion
April 15, 2021
Study Completion
May 1, 2021
Last Updated
July 9, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share