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NCT Number: NCT07076966

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

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.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital, Hsinchu Branch, Hsinchu, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D device

Device

Use 3D machine to generate the 3D image

Primary outcomes

  1. Adenoma detection rate

    Time frame: 30 minutes

Secondary outcomes

  1. Flat-ADR

    Time frame: 30 minutes

    detection rate of flat adenoma

  2. Proximal ADR

    Time frame: 30 minutes

    detection rate of adenoma at proximal colon

  3. Distal ADR

    Time frame: 30 minutes

    detection rate of adenoma at distal colon

  4. SSLDR

    Time frame: 30 minutes

    detection rate of sessile serrated lesion

  5. AADR

    Time frame: 30 minutes

    detection rate of advanced adenoma

  6. Detection of of adenoma with various size

    Time frame: 30 minutes

  7. Polyp detection rate

    Time frame: 30 minutes

  8. Adenoma number per colonoscopy,

    Time frame: 30 minutes

  9. Polyp number per colonoscopy

    Time frame: 30 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Li-Chun Chang, MD. PhD.

CONTACT

[email protected]

886-9-72-651-258

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 22, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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