Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy

Not Applicable

Withdrawn

• Conditions: Colorectal Neoplasms
• Interventions: Other: Chromoendoscopy; Other: High definition white light endoscopy; Device: Narrow band imaging

• Registration Number: NCT04192929
• Lead Sponsor: Indiana University

Brief Summary

Narrow band imaging or electronic chromoendoscopy might provide similar adenoma detection capabilities while limiting time spent when compared to conventional chromoendoscopy method.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Status Verified: 2023-10
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Study Start: 2025-02
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age ≥ 40 years
2. Referral for screening, surveillance or diagnostic colonoscopy

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Exclusion Criteria

1. Inflammatory bowel disease
2. History of colorectal cancer or colon resection
3. Indication of positive FIT or cologuard
4. Any colorectal cancer syndromes (FAP, HNPCC, SPS)
5. Patient with poor bowel preparation identified during insertion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chromoendoscopy	Chromoendoscopy	indigo carmine is sprayed on the colon mucosa during withdrawal phase
High definition white light endoscopy	High definition white light endoscopy	colonoscopy performed using high definition equipment
Narrow band imaging	Narrow band imaging	Narrow band imaging is used during withdrawal phase

Primary Outcome Measures

Name	Time	Method
Adenomas per colonoscopy	during the procedure	total number of adenomas divided by total number of procedures

Secondary Outcome Measures

Name	Time	Method
Sessile serrated polyps per colonoscopy	during the procedure	total number of sessile serrated polyps divided by total number of procedures
Sessile serrated polyp detection rate	during the procedure	total number of patients with sessile serrated polyps divided by total number of procedures
Adenoma detection rate	during the procedure	total number of patients with adenomas divided by total number of procedures
Withdrawal time	during the procedure	Time from cecal intubation to end of the procedure
Inspection time	during the procedure	Time during withdrawal minus time for interventions including washing, suctioning and polypectomy or biopsies

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States