Adenoma Detection Rate of 3D Colonoscopy

Last updated: September 17, 2024
Sponsor: National Taiwan University Hospital
Overall Status: Completed

Phase

N/A

Condition

Colon Cancer

Cancer

Rectal Cancer

Treatment

3D colonoscopy

Clinical Study ID

NCT05153746
202109112DIPB
  • Ages > 40
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 40 or above

  • Indication for colonoscopy, including screening, surveillance, symptomatic, etc

Exclusion

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.)

Study Design

Total Participants: 318
Treatment Group(s): 1
Primary Treatment: 3D colonoscopy
Phase:
Study Start date:
February 10, 2022
Estimated Completion Date:
June 01, 2023

Study Description

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.

Connect with a study center

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

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