Clinical trial NCT04464135: Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Colonoscopy
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenoma Colon
Keywords: Water exchange colonoscopy
Flat Polyps
Acetic Acid Staining
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of flat polyps per patient
timeFrame: 9 months
Secondary outcomes:
measure: Overall ADR
timeFrame: 9 months
measure: Advanced ADR
timeFrame: 9 months
measure: SSA/P detection rate
timeFrame: 9 months
measure: Flat neoplasms located in proximal colon
timeFrame: 9 months
measure: Adverse events
timeFrame: 9 months
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University
state: Gansu
city: Shenzhen
country: China
facility: Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University
state: Guangdong
city: Kaifeng
country: China
facility: Department of Gastroenterology, Huaihe Hospital of Henan University
state: Henan
city: Xi'an
country: China
facility: Department of Gastroenterology, Shaanxi Second People's Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases
name: Yanglin Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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 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.
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 and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
citation: 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.