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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Colonoscopy Adenoma Detection Rate Three Dimensional Colon Polyps and Adenomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3D colonoscopy versus standard 2D colonoscopy

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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3D colonoscopy

Group Type EXPERIMENTAL

3D device

Intervention Type DEVICE

Use 3D machine to generate the 3D image

2D colonoscopy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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3D device

Use 3D machine to generate the 3D image

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No