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Right Colon Polyp Miss Rates of Water Exchange and Carbon Dioxide Insufflation Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03845933
Recruitment Status : Completed
First Posted : February 19, 2019
Results First Posted : December 13, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Chi-Liang Cheng, Evergreen General Hospital, Taiwan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Right Colon Adenoma Miss Rate Right Colon Hyperplastic Polyp Miss Rate Procedure: Colon polypectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The second endoscopist will perform tandem right colon examination and is blinded to the insertion method used by the first endoscopist.
Primary Purpose: Treatment
Official Title: Comparing Right Colon Adenoma and Hyperplastic Polyp Miss Rate in Colonoscopy Using Water Exchange and Carbon Dioxide Insufflation: A Prospective Randomized Controlled Trial
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


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.
Procedure: Colon polypectomy
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.
Procedure: Colon polypectomy
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845933


Locations
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Taiwan
Evergreen General Hospital
Taoyuan, Taiwan
Sponsors and Collaborators
Evergreen General Hospital, Taiwan
Investigators
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Principal Investigator: Chiliang Cheng, MD Evergreen General Hospital
  Study Documents (Full-Text)

Documents provided by Chi-Liang Cheng, Evergreen General Hospital, Taiwan:

Publications:
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Responsible Party: Chi-Liang Cheng, M.D., Evergreen General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03845933    
Other Study ID Numbers: EGH-2019
First Posted: February 19, 2019    Key Record Dates
Results First Posted: December 13, 2019
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Polyps
Hyperplasia
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes