Clinical trial NCT05153746: Adenoma Detection Rate of 3D Colonoscopy
Official title: Comparison of Adenoma Detection Rate Between Conventional Colonoscopy and 3D Colonoscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Colorectal Cancer
Keywords: 3D Colonoscopy
Colorectal neoplasm
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 318
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3D-colonoscopy vs. conventional 2D-colonoscopy Setting: Multi-centers

Eligibility:

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

Exclusion:

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.)
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 1 week
Secondary outcomes:
measure: Proximal adenoma detection rate
timeFrame: 1 weeks
measure: Sessile serrated adenoma detection rate
timeFrame: 1 week
measure: Adenoma per colonoscopy (APC)
timeFrame: 1 week
measure: Flat adenoma detection rate
timeFrame: 1 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Li-Chun Chang, AP
role: STUDY_DIRECTOR
References: