Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Colonoscopy
Primary Purpose
Adenoma Colon
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acetic acid staining
Water exchange colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenoma Colon focused on measuring Water exchange colonoscopy, Flat Polyps, Acetic Acid Staining
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
Sites / Locations
- Department of Gastroenterology, Second Affiliated Hospital, Lanzhou UniversityRecruiting
- Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical UniversityRecruiting
- Department of Gastroenterology, Huaihe Hospital of Henan UniversityRecruiting
- Department of Gastroenterology, Shaanxi Second People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
WE+AA group
WE group
Arm Description
Water containing 1% of AA was used during insertion of colonoscopy using water exchange method.
Water exchange colonoscopy was used for standard screening or surveillance colonoscopy.
Outcomes
Primary Outcome Measures
Number of flat polyps per patient
average numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient
Secondary Outcome Measures
Overall ADR
Adenoma detection rate, defined as the proportion of subjects with at least one adenoma of any size, in each group.
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.
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.
Flat neoplasms located in proximal colon
Low-grade adenoma, adenoma with villous components, high-grade adenoma, noninvasive carcinoma, and invasive carcinoma in proximal colon
Adverse events
the rate of bleeding and perforation during colonoscopy procedure and abdominal pain, diarrhea, hematochezia and change of defecation habit Within one week.
Full Information
NCT ID
NCT04464135
First Posted
July 7, 2020
Last Updated
July 7, 2020
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT04464135
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2020 (Anticipated)
Primary Completion Date
April 15, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Colon
Keywords
Water exchange colonoscopy, Flat Polyps, Acetic Acid Staining
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WE+AA group
Arm Type
Experimental
Arm Description
Water containing 1% of AA was used during insertion of colonoscopy using water exchange method.
Arm Title
WE group
Arm Type
Active Comparator
Arm Description
Water exchange colonoscopy was used for standard screening or surveillance colonoscopy.
Intervention Type
Other
Intervention Name(s)
acetic acid staining
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Water exchange colonoscopy
Intervention Description
The water exchange colonoscopy is used during insertion procedure, and the liquid is absorbed during the withdrawal process for observation.
Primary Outcome Measure Information:
Title
Number of flat polyps per patient
Description
average numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Overall ADR
Description
Adenoma detection rate, defined as the proportion of subjects with at least one adenoma of any size, in each group.
Time Frame
9 months
Title
Advanced ADR
Description
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.
Time Frame
9 months
Title
SSA/P detection rate
Description
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.
Time Frame
9 months
Title
Flat neoplasms located in proximal colon
Description
Low-grade adenoma, adenoma with villous components, high-grade adenoma, noninvasive carcinoma, and invasive carcinoma in proximal colon
Time Frame
9 months
Title
Adverse events
Description
the rate of bleeding and perforation during colonoscopy procedure and abdominal pain, diarrhea, hematochezia and change of defecation habit Within one week.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gui Ren, MD
Phone
+86298477136
Email
renguigz@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanglin Pan, MD
Phone
+862984771536
Email
yanglinpan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanglin Pan, MD
Organizational Affiliation
Xijing Hospital of Digestive Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Huang, MD
Phone
+8609318942279
Email
haungxj62@163.com
Facility Name
Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoying Zhang, MD
Phone
+8613116950266
Email
13116950266@163.com
Facility Name
Department of Gastroenterology, Huaihe Hospital of Henan University
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
475000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianghai Zhao, MD
Phone
+8615191903630
Email
493109907@qq.com
Facility Name
Department of Gastroenterology, Shaanxi Second People's Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Limei Wang, MD
Phone
+8615291680602
Email
15291680602@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24804989
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.
Results Reference
background
PubMed Identifier
27922025
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.
Results Reference
result
PubMed Identifier
30738046
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.
Results Reference
result
PubMed Identifier
28365356
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.
Results Reference
result
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Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Colonoscopy
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