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

NCT ID: NCT03845933

Last Updated: 2019-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-10-31

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.

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.

Conditions

Right Colon Adenoma Miss Rate; Right Colon Hyperplastic Polyp Miss Rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Colon polypectomy

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Colon polypectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evergreen General Hospital, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Chi-Liang Cheng

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chiliang Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Evergreen General Hospital

Locations

Evergreen General Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

References

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Reference Type: BACKGROUND

PMID: 23744612 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

PMID: 33074950 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EGH-2019

Identifier Type: -

Identifier Source: org_study_id