Adenoma Miss Rate With Water Exchange vs Carbon Dioxide Colonoscopy

• ClinicalTrials.gov Identifier: NCT03832322
• Recruitment Status: Completed
• First Posted: February 6, 2019
• Results First Posted: May 10, 2019
• Last Update Posted: May 21, 2019
• Sponsor: Evergreen General Hospital, Taiwan
• Information provided by (Responsible Party): Chi-Liang Cheng, Evergreen General Hospital, Taiwan

Study Description

Brief Summary:

This was an observational study comparing consecutive group of WE and CO2 insufflation in terms of right and proximal colon AMR by tandem colonoscopy.

Condition or disease	Intervention/treatment
Colonic Adenoma; Water Exchange Colonoscopy	Procedure: Water exchange colonoscopy; Procedure: CO2 insufflation colonoscopy

Detailed Description:

This was a prospective observational study to assess how WE colonoscopy would fit into clinical and research practices. We first observed whether optimal WE colonoscopy decreased the AMR in the right and proximal colon in a tandem approach. If WE did lower the AMR as compared with data in the literature, a randomized RCT deserves to be studied. For the calculation of sample size in the upcoming RCT, the AMR in the CO2 group would be collected. The differences of the AMRs in the right and proximal colon determined by tandem colonoscopy using WE or CO2 insufflation would then be compared.

Study Design

• Study Type: Observational
• Actual Enrollment: 176 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Water Exchange Colonoscopy Decreased Adenoma Miss Rates in the Right and Proximal Colon: An Observational Study Using A Tandem Colonoscopy Approach
• Actual Study Start Date: July 9, 2018
• Actual Primary Completion Date: November 28, 2018
• Actual Study Completion Date: November 28, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Water exchange colonoscopy; During the insertion phase of the first-pass colonoscopy, water exchange (WE) method was used. WE entailed the infusion of water to open the lumen and sequentially suction of water. When the cecum was reached and after most of the water was suctioned to collapse the cecal lumen, CO2 was opened during the withdrawal phase of the first-pass colonoscopy. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.	Procedure: Water exchange colonoscopy; During back-to-back colonoscopy, the first examination was completed with water exchange during insertion and CO2 insufflation during withdrawal. The second examination was completed with CO2 insufflation during both the insertion and withdrawal.; Procedure: CO2 insufflation colonoscopy; During back-to-back colonoscopy, the first examination was completed with CO2 insufflation during both the insertion and withdrawal. The second examination was also completed with CO2 insufflation during both the insertion and withdrawal.
CO2 insufflation colonoscopy; During the first-pass colonoscopy, the procedure was performed in the usual fashion, with minimal CO2 insufflation to aid insertion. Cleaning of colon was predominantly performed during withdrawal. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.	Procedure: CO2 insufflation colonoscopy; During back-to-back colonoscopy, the first examination was completed with CO2 insufflation during both the insertion and withdrawal. The second examination was also completed with CO2 insufflation during both the insertion and withdrawal.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Overall Detected Adenomas Missed During the First Right-Colon Colonoscopy [ Time Frame: During procedure, approximately 1.5 hours ]
   Right-colon (cecum, A-colon, hepatic flexure) adenomas detected on the second-pass examination were used for the calculation of adenoma miss. Adenoma miss rate was calculated as the number of adenomas missed in the first colonoscopy divided by the total number of adenomas detected during both the first and second colonoscopies.
2. Percentage of Overall Detected Adenomas Missed During the First Proximal-Colon Colonoscopy [ Time Frame: During procedure, approximately 1.5 hours ]
   Proximal-colon (cecum, A-colon, hepatic flexure, T-colon) adenomas detected on the second-pass examination were used for the calculation of adenoma miss. Adenoma miss rate was calculated as the number of adenomas missed in the first colonoscopy divided by the total number of adenomas detected during both the first and second colonoscopies.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

86 eligible patients completed first-pass colonoscopy with WE insertion and CO2 withdrawal, followed by back-to-back second-pass colonoscopy with CO2 insertion and CO2 withdrawal during July 9 to Oct 12, 2018; Another 86 eligible patient completed first-pass colonoscopy with CO2 insertion and CO2 withdrawal, followed by back-to-back second-pass colonoscopy with CO2 insertion and CO2 withdrawal during Oct 15 to Nov 21, 2018.

Criteria

Inclusion Criteria:

• Consecutive patients aged 20 years or older undergoing colonoscopy for screening and surveillance indications were considered for enrollment.

Exclusion Criteria:

• familial adenomatous polyposis and hereditary non-polyposis CRC syndrome, personal history of inflammatory bowel disease, previous colonic resection, inability to achieve cecal intubation, obstructive lesions of the colon, poor colon preparation, inability to completely remove a polyp, gastrointestinal bleeding, allergy to fentanyl or midazolam, American Society of Anesthesiology classification of physical status grade 3 or higher, mental retardation, pregnancy, and refusal to provide a written informed consent.

Contacts and Locations

Locations

Taiwan

Evergreen General Hospital

Taoyuan, Taiwan, 320

Sponsors and Collaborators

Evergreen General Hospital, Taiwan

Investigators

• Principal Investigator: Chi-Liang Cheng; Evergreen General Hospital, Taoyuan, Taiwan

  Study Documents (Full-Text)

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

Study Protocol and Statistical Analysis Plan  [PDF] January 3, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 CO(2) insufflation: an observational study. BMC Gastroenterol. 2019 Aug 14;19(1):143. doi: 10.1186/s12876-019-1065-2.

• Responsible Party: Chi-Liang Cheng, M.D., Evergreen General Hospital, Taiwan
• ClinicalTrials.gov Identifier: NCT03832322
• Other Study ID Numbers: EGH-2018
• First Posted: February 6, 2019
• Results First Posted: May 10, 2019
• Last Update Posted: May 21, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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

Adenoma miss rate; Adenoma detection rate

Additional relevant MeSH terms:

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms