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

Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Surveillance Colonoscopy: A Multi-center, Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07076966
Enrollment
500
Registered
2025-07-22
Start date
2024-01-01
Completion date
2027-02-28
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Colonoscopy, adenoma detection rate, 3D, surveillance colonoscopy

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.

Interventions

DEVICE3D device

Use 3D machine to generate the 3D image

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

3D colonoscopy versus standard 2D colonoscopy

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Adenoma detection rate30 minutes

Secondary

MeasureTime frameDescription
Polyp number per colonoscopy30 minutes
Flat-ADR30 minutesdetection rate of flat adenoma
Proximal ADR30 minutesdetection rate of adenoma at proximal colon
Distal ADR30 minutesdetection rate of adenoma at distal colon
Adenoma number per colonoscopy,30 minutes
AADR30 minutesdetection rate of advanced adenoma
Detection of of adenoma with various size30 minutes
Polyp detection rate30 minutes
SSLDR30 minutesdetection rate of sessile serrated lesion

Countries

Taiwan

Contacts

Primary ContactLi-Chun Chang, MD. PhD.
lichunchang@ntu.edu.tw886-9-72-651-258

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026