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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04464135
Other study ID # KY20200706-3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2020
Est. completion date May 1, 2021

Study information

Verified date July 2020
Source Fourth Military Medical University
Contact Gui Ren, MD
Phone +86298477136
Email renguigz@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 1, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
acetic acid staining
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.
Water exchange colonoscopy
The water exchange colonoscopy is used during insertion procedure, and the liquid is absorbed during the withdrawal process for observation.

Locations

Country Name City State
China Department of Gastroenterology, Huaihe Hospital of Henan University Kaifeng Henan
China Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University Lanzhou Gansu
China Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University Shenzhen Guangdong
China Department of Gastroenterology, Shaanxi Second People's Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Gastrointes — View Citation

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 Detecti — View Citation

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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of flat polyps per patient average numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient 9 months
Secondary Overall ADR Adenoma detection rate, defined as the proportion of subjects with at least one adenoma of any size, in each group. 9 months
Secondary Advanced ADR 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
Secondary SSA/P detection rate 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
Secondary Flat neoplasms located in proximal colon Low-grade adenoma, adenoma with villous components, high-grade adenoma, noninvasive carcinoma, and invasive carcinoma in proximal colon 9 months
Secondary Adverse events the rate of bleeding and perforation during colonoscopy procedure and abdominal pain, diarrhea, hematochezia and change of defecation habit Within one week. 9 months
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