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Recruiting NCT07076966

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

No phase Interventional Colonoscopy Adenoma Detection Rate Three Dimensional Colon Polyps and Adenomas

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3D device.
Who it may be relevant to
Registry conditions: Colonoscopy, Adenoma Detection Rate, Three Dimensional, Colon Polyps and Adenomas. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Device 3D device
    Use 3D machine to generate the 3D image

Primary outcome measures

  • Adenoma detection rate [Time frame: 30 minutes]
Secondary outcome measures (9)
  • Flat-ADR [Time frame: 30 minutes]
  • Proximal ADR [Time frame: 30 minutes]
  • Distal ADR [Time frame: 30 minutes]
  • SSLDR [Time frame: 30 minutes]
  • AADR [Time frame: 30 minutes]
  • Detection of of adenoma with various size [Time frame: 30 minutes]
  • Polyp detection rate [Time frame: 30 minutes]
  • Adenoma number per colonoscopy, [Time frame: 30 minutes]
  • Polyp number per colonoscopy [Time frame: 30 minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Diagnostic

Study locations

Taiwan · 3 centers
  • National Taiwan University Hospital, Hsinchu Branch — Hsinchu
  • National Taiwan University Cancer Center — Taipei
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT07076966 · 202311019DIPC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗