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

Adenoma Colon Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04464135
• Other study ID #: KY20200706-3
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon

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