Clinical Trials Directory

Trials / Completed

CompletedNCT05153746

Adenoma Detection Rate of 3D Colonoscopy

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
318 (actual)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICE3D colonoscopy3D colonoscopy is a new device to enhance endoscopic imaging.

Timeline

Start date
2022-02-10
Primary completion
2023-05-23
Completion
2023-06-01
First posted
2021-12-10
Last updated
2024-09-19

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT05153746. Inclusion in this directory is not an endorsement.