Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy
Primary Purpose
Adenoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Water exchange (WE) method
Air insufflation (AI) method.
Sponsored by
About this trial
This is an interventional treatment trial for Adenoma focused on measuring Water exchange colonoscopy, Adenoma miss rate, Polyps
Eligibility Criteria
Inclusion Criteria:
- Age 18-80 patients undergoing selective polypectomy
Exclusion Criteria:
- Polyps found more than 6 months
- Patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer
- Patients with history of inflammatory bowel disease
- Patients with planning to undergo Endoscopic Submucosal Dissection(ESD)
- Patients not undergoing standard bowel preparation
- Patients with solid feces in the last stool after bowel preparation
- Patients considered to be high risk for bleeding during Endoscopic mucosal resection (EMR), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy
- Hemodynamically unstable
- Pregnant women
- Unable to provide informed consent
Sites / Locations
- Endoscopic center, Xijing Hospital of Digestive DiseasesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Water exchange (WE) method
Air insufflation (AI) method
Arm Description
Water exchange (WE) method was used for insertion to the cecum.
Air insufflation (AI) method was used for insertion to the cecum.
Outcomes
Primary Outcome Measures
Adenoma miss rate
Adenoma miss rate was calculated as the number of patients with one and more additional adenomas during polypectomy procedure divided by the total number of patients in each group.
Secondary Outcome Measures
adenoma-level miss rate
Adenoma-level miss rate was calculated as the number of additional adenomas detected in polypectomy procedure divided by the total number of adenomas in each group.
Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy
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.
Adenoma per positive patient (APP)
The mean number of adenoma per positive patient
Quality of Bowel Preparation
The Boston Bowel Preparation Scale (BBPS): cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.
Complication rate
Bleeding, perforation and others
Pain Scores on the Visual Analog Scale compared with previous colonoscopy
0 = no pain, to 10 = most severe pain
Full Information
NCT ID
NCT02880748
First Posted
August 19, 2016
Last Updated
August 25, 2016
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT02880748
Brief Title
Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy
Official Title
Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy: a Single-centered, Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with colorectal adenomas are suggested to receive polypectomy. A substantial number of adenomas may be missed in patients with polyps found by previous colonoscopy. And water exchange (WE) method may increase the detection of missed adenoma compared with traditional air insufflation (AI) colonoscopy. The investigators aim to investigate whether water exchange colonoscopy method, compared with air insufflation method, can improve the detection of missed adenomas in patients undergoing selective polypectomy.
Detailed Description
For WE method, the air pump was turned off for the full duration of insertion to avoid inadvertent air insufflations and colon elongation. Residual air in the lumen was suctioned to minimize angulations at flexures. Water at 37°C was infused with a pump (Olympus) through the biopsy channel to confirm correct tip orientation for scope advancement. The infused water was removed predominantly by suction when the colonoscope was smoothly advanced during the insertion phase, and turbid luminal water due to residual feces was exchanged by clean water until the lumen was clearly visualized. Occasionally, if it was difficult to determine whether the colonoscope tip was in the cecum, air was allowed to be insufflated for observation. If the position of the scope tip was confirmed to be not in the cecum, insufflated air would be removed by suction and the WE method would be continuously used until successful intubation.
For the AI method, water was not used, and air was insufflated during insertion.
Air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal for both methods. Polyps will be removed by forceps biopsy (polyps size <3mm), cold snare technique (3-6mm) or endoscopic mucosal resection (size≥6mm).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma
Keywords
Water exchange colonoscopy, Adenoma miss rate, Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Water exchange (WE) method
Arm Type
Experimental
Arm Description
Water exchange (WE) method was used for insertion to the cecum.
Arm Title
Air insufflation (AI) method
Arm Type
Active Comparator
Arm Description
Air insufflation (AI) method was used for insertion to the cecum.
Intervention Type
Other
Intervention Name(s)
Water exchange (WE) method
Intervention Description
Water exchange (WE) method was used for insertion to the cecum. And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
Intervention Type
Other
Intervention Name(s)
Air insufflation (AI) method.
Intervention Description
Air insufflation (AI) method was used for insertion to the cecum. And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
Primary Outcome Measure Information:
Title
Adenoma miss rate
Description
Adenoma miss rate was calculated as the number of patients with one and more additional adenomas during polypectomy procedure divided by the total number of patients in each group.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
adenoma-level miss rate
Description
Adenoma-level miss rate was calculated as the number of additional adenomas detected in polypectomy procedure divided by the total number of adenomas in each group.
Time Frame
12 months
Title
Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy
Description
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
12 months
Title
Adenoma per positive patient (APP)
Description
The mean number of adenoma per positive patient
Time Frame
12 months
Title
Quality of Bowel Preparation
Description
The Boston Bowel Preparation Scale (BBPS): cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.
Time Frame
12 months
Title
Complication rate
Description
Bleeding, perforation and others
Time Frame
12 months
Title
Pain Scores on the Visual Analog Scale compared with previous colonoscopy
Description
0 = no pain, to 10 = most severe pain
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-80 patients undergoing selective polypectomy
Exclusion Criteria:
Polyps found more than 6 months
Patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer
Patients with history of inflammatory bowel disease
Patients with planning to undergo Endoscopic Submucosal Dissection(ESD)
Patients not undergoing standard bowel preparation
Patients with solid feces in the last stool after bowel preparation
Patients considered to be high risk for bleeding during Endoscopic mucosal resection (EMR), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy
Hemodynamically unstable
Pregnant women
Unable to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gui Ren, MD
Phone
+86298477136
Email
renguigz@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
Endoscopic center, Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gui Ren, MD
Phone
+862984771536
Email
renguigz@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gui Ren, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26873868
Citation
Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, Dumonceau JM. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Gut. 2016 Mar;65(3):374-89. doi: 10.1136/gutjnl-2015-311110.
Results Reference
background
PubMed Identifier
20579648
Citation
Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc. 2010 Oct;72(4):775-81. doi: 10.1016/j.gie.2010.04.030. Epub 2010 Jun 25.
Results Reference
background
PubMed Identifier
33390353
Citation
Ren G, Wang X, Luo H, Yao S, Liang S, Zhang L, Dong T, Chen L, Tao Q, Guo X, Han Y, Pan Y. Effect of water exchange method on adenoma miss rate of patients undergoing selective polypectomy: A randomized controlled trial. Dig Liver Dis. 2021 May;53(5):625-630. doi: 10.1016/j.dld.2020.11.012. Epub 2020 Dec 31.
Results Reference
derived
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Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy
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