Comparison of Adenoma Detection Rate in 3D vs. 2D Surveillance Colonoscopy

Not Applicable

Recruiting

• Conditions: Colonoscopy; Adenoma Detection Rate; Three Dimensional; Colon Polyps and Adenomas

• Registration Number: NCT07076966
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

There is substantial evidence confirming that identifying and removing colorectal adenomas during colonoscopy helps prevent the development of colorectal cancer. Among the quality indicators for colonoscopy, adenoma detection rate (ADR) is the most important, as it is closely related to the patient's future risk of colorectal cancer. Recent studies have further demonstrated that improving ADR can reduce future mortality from colorectal cancer. Notably, non-polypoid lesions (such as flat or depressed lesions) are more likely to be missed during traditional colonoscopy, making these lesions a leading cause of post-colonoscopy interval colorectal cancer.

In a prospective trial conducted by our team comparing the ADR of 3D colonoscopy with standard 2D colonoscopy, we found that 3D colonoscopy significantly improved overall ADR and the detection rate of non-polypoid adenomas.

According to current international guidelines, after an index colonoscopy, patients are recommended to undergo surveillance colonoscopy 1 to 10 years later, depending on their findings at index colonoscopy. Since these patients represent the majority in clinical practice, increasing the ADR during surveillance colonoscopy not only allows for more precise recommendations for the timing of the next colonoscopy but also effectively reduces the risk of post-colonoscopy colorectal cancer (PCCRC).

Therefore, this multicenter, prospective, randomized trial aims to compare the clinical performance of 3D colonoscopy and standard 2D colonoscopy in the context of surveillance colonoscopy.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-10-22
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-19
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-12-31
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Subjects who are 40 years of older
• Subjects who receive colonoscopy and polypectomy more the 1 year
• Subjects who need surveillance colonoscopy

Exclusion Criteria

• Contraindication for colonoscopy
• Subjects with familiar or hereditary polyposis
• Subjects with history of colectomy
• Inadequate bowel cleansing level
• Subjects with inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	30 minutes

Secondary Outcome Measures

Name	Time	Method
Flat-ADR	30 minutes	detection rate of flat adenoma
Proximal ADR	30 minutes	detection rate of adenoma at proximal colon
Distal ADR	30 minutes	detection rate of adenoma at distal colon
SSLDR	30 minutes	detection rate of sessile serrated lesion
AADR	30 minutes	detection rate of advanced adenoma
Detection of of adenoma with various size	30 minutes
Polyp detection rate	30 minutes
Adenoma number per colonoscopy,	30 minutes
Polyp number per colonoscopy	30 minutes

Trial Locations

Locations (3)

National Taiwan University Hospital, Hsinchu Branch; 🇨🇳 Hsinchu, Taiwan

National Taiwan University Cancer Center; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan