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Multicenter Evaluation of Right Colon Polyp Miss Rates Using Water Exchange Versus CO2 Insufflation

E

Evergreen General Hospital, Taiwan

Status

Completed

Conditions

Right Colon Hyperplastic Polyp Miss Rate
Right Colon Adenoma Miss Rate

Treatments

Procedure: Colon Polypectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04124393
EGH-2020

Details and patient eligibility

About

A prospective multicenter randomized controlled trial (RCT) comparing water exchange (WE) colonoscopy and carbon dioxide (CO2) insufflation in terms of right colon combined adenoma miss rate (AMR) and hyperplastic polyp miss rate (HPMR) by tandem inspection.

Full 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 will be a multicenter study conducted in three community hospitals (Evergreen General Hospital, Taoyuan; Dalin Tzu-Chi Hospital, Chiayi; Taipei Medical University Hospital, Taipei) in Taiwan. Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive FIT will be considered for enrollment from December 2019 to May 2021. A written informed consent will be obtained from all participating patients. Participants will be randomized in a 1:1 ratio to undergo either the CO2 insufflation colonoscopy (CO2 group) or WE colonoscopy (WE group). WE colonoscopies will be performed by five board-certified colonoscopists (Chi-Liang Cheng, Yen-Lin Kuo [Evergreen General Hospital]; Yu-Hsi Hsieh, Chih-Wei Tseng [Dalin Tzu-Chi Hospital]; Jui-Hsiang Tang [Taipei Medical University Hospital]. Standard colonoscopes (CF-Q260AL/I, CF-HQ290L/I; Olympus Medical Systems Corp., Tokyo, Japan) will be used. Felix W. Leung will be involved in the study design, data analyses, and report preparation, but not in patient enrollment. Antispasmodic medication will not be administered during colonoscopy examination. 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 and after most of the water is suctioned to collapse the cecal lumen, 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 blinded endoscopist 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.

Enrollment

386 patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive fecal immunochemical test will be considered for enrollment.

Exclusion criteria

  • Familial adenomatous polyposis and hereditary non-polyposis colorectal cancer (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 classification of physical status grade 3 or higher, mental retardation, pregnancy, and refusal to provide a written informed consent.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

386 participants in 2 patient groups

Water Exchange (WE) Colonoscopy
Active Comparator group
Description:
In the WE group, the air pump will be turned off before starting the procedure. During the insertion phase, the colon will be irrigated with warm water (32C-35C). WE entails the infusion of water to open the lumen and simultaneous suction if the endoscope has two channels, and sequentially if the endoscope has only one channel. When the cecum is reached and after most of the water is suctioned to collapse the cecal lumen, CO2 will be opened. The colonoscope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). The colonoscope will then be reinserted into the cecum by the first endoscopist. A tandem inspection of the right colon will be performed by a blinded 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.
Treatment:
Procedure: Colon Polypectomy
CO2 Insufflation Colonoscopy
Active Comparator group
Description:
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 and the colonoscope will be withdrawn from the cecum to the hepatic flexure. All polyps identified will be resected (colon polypectomy). Then, the colonoscope will be reinserted into the cecum by the first endoscopist. A tandem inspection of the right colon will be performed by a blinded 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.
Treatment:
Procedure: Colon Polypectomy

Trial contacts and locations

1

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Central trial contact

Chiliang Cheng, M.D.; Chiliang Cheng, M.D.

Data sourced from clinicaltrials.gov

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