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

NCT07076966 | Recruiting DMC

• 1 other identifier: 202311019DIPC
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

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.

Conditions

Colonoscopy; Adenoma Detection Rate; Three Dimensional; Colon Polyps and Adenomas

Keywords

Colonoscopy; adenoma detection rate; 3D; surveillance colonoscopy

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  30 minutes

Secondary Outcomes (9)

• Flat-ADR

  30 minutes

• Proximal ADR

  30 minutes

• Distal ADR

  30 minutes

• SSLDR

  30 minutes

• AADR

  30 minutes

Study Arms (2)

3D colonoscopy

EXPERIMENTAL

Device: 3D device

2D colonoscopy

NO INTERVENTION

Interventions

3D device DEVICE

Use 3D machine to generate the 3D image

3D colonoscopy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (3)

National Taiwan University Hospital, Hsinchu Branch

Hsinchu, Taiwan, Taiwan

RECRUITING

National Taiwan University Cancer Center

Taipei, Taiwan, 100, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Colonic Polyps; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Li-Chun Chang, MD. PhD.

CONTACT

886-9-72-651-258; lichunchang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician, Department of Internal Medicine

Model Details: 3D colonoscopy versus standard 2D colonoscopy

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: July 22, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

TW (3)