- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03845933
Right Colon Polyp Miss Rates of Water Exchange and Carbon Dioxide Insufflation Colonoscopy
December 12, 2019 updated by: Chi-Liang Cheng, Evergreen General Hospital, Taiwan
Comparing Right Colon Adenoma and Hyperplastic Polyp Miss Rate in Colonoscopy Using Water Exchange and Carbon Dioxide Insufflation: A Prospective Randomized Controlled Trial
This will be a prospective randomized controlled trial comparing CO2 insufflation and WE in terms of right colon combined adenoma miss rate (AMR) and hyperplastic polyp miss rate (HPMR) by tandem inspection.
It will be a single-site study conducted in Taiwan.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This will be a prospective RCT comparing CO2 insufflation and WE in terms of right colon combined AMR and HPMR by tandem inspection.
It is originally designed as a multicenter study conducted in three community hospitals in Taiwan.
Consecutive patients will be enrolled from April 2019 to October 2020.
A written informed consent will be obtained from all participating patients.
The study has obtained ethical approval from the Joint Institutional Review Board of Taiwan (19-002-T-1) and has been registered with ClinicalTrials.gov
(NCT03845933).
Due to delay in obtaining IRB approval in two of the participating hospitals (Dalin Tzu-Chi Hospital obtained IRB approval in late May 2019 and has not recruited any patient; Taipei Medical University Hospital has not obtained IRB approval in early June 2019) and rapid recruitment of Evergreen General Hospital since April 2019, which has recruited and completed more than 90 patients in the end of May 2019, we have amended the study design from multicenter study to single-center study and have obtained the approval of this amendment from the Joint Institutional Review Board of Taiwan.
Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive FIT will be considered for enrollment from April 2019 to October 2020.
Participants will be randomized in a 1:1 ratio to undergo either the CO2 insufflation colonoscopy (CO2 group) or WE colonoscopy (WE group).
Colonoscopies will be performed by two board-certified colonoscopists (Chi-Liang Cheng, Yen-Lin Kuo).
Standard colonoscopes (CF-Q260AL/I; Olympus Medical Systems Corp., Tokyo, Japan) will be used.
All colonoscopists have performed more than 1000 conventional colonoscopies.
Hands-on coaching by a WE expert (Felix W. Leung) to standardize the WE method has been completed.
Each colonoscopist has completed 100 cases of WE learning curve.
Felix W. Leung will be involved in the study design, data analyses, and report preparation, but not in patient enrollment.
CO2 insufflation will be used for CO2 group and the withdrawal phase of the WE group.
In the WE group, the air pump will be turned off before starting the procedure.
During the insertion phase, air and residual water or feces in the rectum will be aspirated, and then the colon will be irrigated with warm water.
When the cecum is reached, CO2 will be opened.
In the CO2 group, colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion.
Cleaning in the CO2 group will be performed entirely during withdrawal.
Upon arriving at the cecum, CO2 insufflation will be used in both groups and the scope will be withdrawn from the cecum to the hepatic flexure, with inspection of the mucosa at the same time.
All polyps identified will be resected and sent for pathology evaluation.
The most distal part of the hepatic flexure will be marked by a forceps biopsy and then the scope will be reinserted into the cecum by the first endoscopist using CO2 insufflation.
A tandem inspection of the right colon will then be performed by a second endoscopist blinded to the insertion method in both study groups.
All polyps found herein will be counted as the missed polyps.
After the second withdrawal to the mark of distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist.
Polyp search and resection will be performed during the withdrawal phase in both groups.
Insertion polypectomy will not be performed.
Study Type
Interventional
Enrollment (Actual)
262
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taoyuan, Taiwan
- Evergreen General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive FIT will be considered for enrollment.
Exclusion Criteria:
- familial adenomatous polyposis and hereditary non-polyposis CRC syndrome, personal history of CRC or inflammatory bowel disease, previous colonic resection, obstructive lesions of the colon, gastrointestinal bleeding, allergy to fentanyl, midazolam or propofol, American Society of Anesthesiology (ASA) classification of physical status grade 3 or higher, mental retardation, pregnancy, and refusal to provide a written informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Water exchange (WE) colonoscopy
Water exchange will be used during colonoscopy insertion.
Upon arriving at the cecum, CO2 will be opened.
The scope will be withdrawn to the hepatic flexure.
All polyps identified will be resected (colon polypectomy).
The scope will be reinserted into the cecum by the first endoscopist.
A tandem inspection of right colon will be performed by a second endoscopist.
All polyps found herein will be counted as the missed polyps.
After the second withdrawal to the distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist.
|
Polyp search and resection will be performed during the withdrawal phase in both groups.
Insertion polypectomy will not be performed.
All proximal colon polyps will be removed irrespective of their size and appearance.
|
Active Comparator: CO2 insufflation colonoscopy
The colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion.
Cleaning will be performed entirely during withdrawal.
Upon arriving at the cecum, CO2 insufflation will be used and the scope will be withdrawn to the hepatic flexure.
All polyps identified will be resected (colon polypectomy).
Then the scope will be reinserted into the cecum by the first endoscopist using CO2.
A tandem inspection of the right colon will then be performed by a second endoscopist.
All polyps found herein will be counted as the missed polyps.
After the second withdrawal to the mark of distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist.
|
Polyp search and resection will be performed during the withdrawal phase in both groups.
Insertion polypectomy will not be performed.
All proximal colon polyps will be removed irrespective of their size and appearance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Adenomas and Hyperplastic Polyps Missed During Initial Right Colon Examination
Time Frame: One day
|
Lesions detected on the tandem (second) right colon examination are used for the calculation of adenoma and hyperplastic polyp miss rate.
Right colon adenoma miss rate (AMR) and right colon hyperplastic polyp miss rate (HPMR) are calculated as the number of adenomas and hyperplastic polyps detected during the second right colon examination divided by the total number of adenoma and hyperplastic polyps detected during both the first and second right colon examinations.
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chiliang Cheng, MD, Evergreen General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- le Clercq CM, Bouwens MW, Rondagh EJ, Bakker CM, Keulen ET, de Ridder RJ, Winkens B, Masclee AA, Sanduleanu S. Postcolonoscopy colorectal cancers are preventable: a population-based study. Gut. 2014 Jun;63(6):957-63. doi: 10.1136/gutjnl-2013-304880. Epub 2013 Jun 6.
- Fuccio L, Frazzoni L, Hassan C, La Marca M, Paci V, Smania V, De Bortoli N, Bazzoli F, Repici A, Rex D, Cadoni S. Water exchange colonoscopy increases adenoma detection rate: a systematic review with network meta-analysis of randomized controlled studies. Gastrointest Endosc. 2018 Oct;88(4):589-597.e11. doi: 10.1016/j.gie.2018.06.028. Epub 2018 Jul 5.
- Leung FW, Koo M, Cadoni S, Falt P, Hsieh YH, Amato A, Erriu M, Fojtik P, Gallittu P, Hu CT, Leung JW, Liggi M, Paggi S, Radaelli F, Rondonotti E, Smajstrla V, Tseng CW, Urban O. Water Exchange Produces Significantly Higher Adenoma Detection Rate Than Water Immersion: Pooled Data From 2 Multisite Randomized Controlled Trials. J Clin Gastroenterol. 2019 Mar;53(3):204-209. doi: 10.1097/MCG.0000000000001012.
- Cheng CL, Kuo YL, Hsieh YH, Tang JH, Leung FW. Comparison of Right Colon Adenoma Miss Rates Between Water Exchange and Carbon Dioxide Insufflation: A Prospective Randomized Controlled Trial. J Clin Gastroenterol. 2021 Nov-Dec 01;55(10):869-875. doi: 10.1097/MCG.0000000000001454.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
October 31, 2019
Study Completion (Actual)
October 31, 2019
Study Registration Dates
First Submitted
February 16, 2019
First Submitted That Met QC Criteria
February 16, 2019
First Posted (Actual)
February 19, 2019
Study Record Updates
Last Update Posted (Actual)
December 17, 2019
Last Update Submitted That Met QC Criteria
December 12, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGH-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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