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Completed

NCT Number: NCT05153746

Adenoma Detection Rate of 3D Colonoscopy

Adenoma detection rate (ADR) has been the most important quality indicator on colonoscopy because ADR was reversely related with CRC incidence and mortality. Several image enhanced technologies, such as narrow-band imaging (NBI) or linked colour imaging (LCI) had been proved to have ability to increase the ADR. 3D techonology, however, has not been validated on colonoscopy performance. Therefore, current study was to compare the ADR between new 3D colonoscopy and conventional 2D colonoscopy.

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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

Taipei, 100, Taiwan

About this study

An accumulating body of evidence has shown that detection and resection of pre-cancerous adenoma by colonoscopy could effectively prevent colorectal cancer (CRC) and its related mortality. Among various colonoscopy quality indicators, such as cecal intubation rate, withdrawal time, and adenoma detection rate (ADR), ADR is the most important one and most closely associated with the subsequent risk of CRC. A recent study further demonstrated the improvement of ADR could reduce subsequent risk of CRC.

To be noted, among all colorectal neoplasm, non-polypoid lesions, such as flat or depressed lesions, carries higher likelihood to be overlooked during conventional colonoscopy and these overlooked lesions were the main etiology of post-colonoscopy colorectal cancer (PCCRC). Nowadays, several colonoscopy technologies had been developed to enhance the detection of colorectal adenoma such as using digital or dye-spray chromoendoscopy or add-on device such as Cap-assisted endoscopy. Among them, some had showed the potential to enhance the detection of non-polypoid lesion, for example, the next-generation NBI or iSCAN.

3D endoscopy is a new technology that using image processing technique to offer more information on tissue depth in comparison with conventional 2D endoscopy. The utility of 3D endoscopy on GI tract was mainly from upper GI tract and it was proved to enhance the diagnostic accuracy on superficial gastric tumors and shortened the procedure time during performing gastric endoscopic submucosal dissection(ESD). However, few is known that whether 3D colonoscopy could enhance the adenoma detection, especially for non-polypoid lesion detection, during colonoscopy examination. Therefore, this prospective, randomized control study is aim to demonstrate the efficacy of 3D colonoscopy on adenoma detection in comparison with conventional 2D colonoscopy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 40 or above
  • Indication for colonoscopy, including screening, surveillance, symptomatic, etc

Exclusion criteria

  • Poor and inadequate bowel preparation
  • Incomplete study because of obstructive lesion, including cancer, stenosis, etc.
  • Failure of cecal intubation, difficult insertion
  • Inflammatory bowel disease
  • Hereditary polyposis, (FAP, Lynch syndrome, hyperplastic polyposis, etc.)

Treatment and study plan

3D colonoscopy

Device

3D colonoscopy is a new device to enhance endoscopic imaging.

Primary outcomes

  1. Adenoma detection rate

    Time frame: 1 week

    The number of subjects with at least one adenomatous polyp found during the colonoscopy

Secondary outcomes

  1. Proximal adenoma detection rate

    Time frame: 1 weeks

    The number of subjects with at least one adenomatous polyp found at proximal colon ( cecum, ascending colon and hepatic flexure) during the colonoscopy

  2. Sessile serrated adenoma detection rate

    Time frame: 1 week

    The number of subjects with at least one sessile serrated adenomatous polyp found during the colonoscopy

  3. Adenoma per colonoscopy (APC)

    Time frame: 1 week

    Average adenomatous polyps number found in each colonoscopy

  4. Flat adenoma detection rate

    Time frame: 1 week

    The number of subjects with at least one flat adenomatous polyp found during the colonoscopy

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Comparison of Adenoma Detection Rate Between Conventional Colonoscopy and 3D Colonoscopy: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2021
Registry last updated
Sep 19, 2024

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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