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

NCT04124393 | Completed

• 1 other identifier: EGH-2020
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Right Colon Adenoma Miss Rate

  Lesions detected on the tandem right colon examination will be used for the calculation of adenoma miss rate. Right colon adenooma miss rate will be calculated as the the number of adenomas missed during the first right colon examination divided by the total number of adenomas detected during both the first and tandem right colon examinations.

  One day

• Right Colon Hyperplastic Polyp Miss Rate

  Lesions detected on the tandem right colon examination will be used for the calculation of hyperplastic polyp miss rate. Right colon hyperplastic polyp miss rate will be calculated as the the number of hyperplastic polyps missed during the first right colon examination divided by the total number of hyperplalstic polyps detected during both the first and tandem right colon examinations.

  One day

Study Arms (2)

Water Exchange (WE) Colonoscopy

ACTIVE COMPARATOR

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 The colonoscope will be withdrawn to the hepatic flexure.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.

Procedure: Colon Polypectomy

CO2 Insufflation Colonoscopy

ACTIVE COMPARATOR

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.

Procedure: Colon Polypectomy

Interventions

Colon Polypectomy PROCEDURE

Polyp search and resection will be performed entirely during the withdrawal phase in both WE and CO2 groups. Insertion inspection and polypectomy will not be performed. All polyps in the proximal colon, defined as cecum, ascending colon, hepatic flexure, and transverse colon, will be removed irrespective of their size and appearance.

CO2 Insufflation Colonoscopy; Water Exchange (WE) Colonoscopy

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evergreen General Hospital, Taiwan: lead
• Taipei Medical University Hospital: collaborator
• Dalin Tzu Chi General Hospital: collaborator
• Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System: collaborator

Study Sites (1)

Evergreen General Hospital

Taoyuan District, Taiwan

Location

Related Publications (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.

  PMID: 23744612 BACKGROUND

• 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.

  PMID: 29981753 BACKGROUND

• 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.

  PMID: 29505552 BACKGROUND

• Cheng CL, Kuo YL, Hsieh YH, Tang JH, Leung FW. Water exchange colonoscopy decreased adenoma miss rates compared with literature data and local data with CO2 insufflation: an observational study. BMC Gastroenterol. 2019 Aug 14;19(1):143. doi: 10.1186/s12876-019-1065-2.

  PMID: 31412789 BACKGROUND

• 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.

  PMID: 30738046 BACKGROUND

• Cheng CL, Tang JH, Hsieh YH, Kuo YL, Fang KC, Tseng CW, Su IC, Chang CC, Tsui YN, Lee BP, Zou KY, Lee YS, Leung FW. Comparing Right-Sided Colon Adenoma and Serrated Polyp Miss Rates With Water Exchange and CO 2 Insufflation: A Randomized Controlled Trial. Am J Gastroenterol. 2024 Oct 30;120(7):1615-1623. doi: 10.14309/ajg.0000000000003168.

  PMID: 39471473 DERIVED

Study Officials

• Chiliang Cheng, M.D.

  Evergreen General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The second endoscopist will perform tandem right colon examination and is blinded to the insertion method used by the first endoscopist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 11, 2019
• Study Start: December 1, 2019
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)