Clinical trial NCT06678477: Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group
Official title: Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group: a Multi-center, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adenoma Detection Rate
Colonoscopy
Three Dimensional
Fecal Immunochemical Test
Keywords: colonoscopy
adenoma detection rate
3D
Fecal immunochemical test
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 250
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 versus standard 2D colonoscopy in positive FIT groups
Primary purpose: DIAGNOSTIC

Brief summary: Background:

Adenoma detection rate is one of the most quality indicator: 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 mortality1,2. 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 CRC3,4. A recent study further demonstrated the improvement of ADR could reduce subsequent risk of CRC5.

Equipment and technique to improve ADR: 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)6. Nowadays, several colonoscopy technologies had been developed to enhance the detection of colorectal adenoma such as using digital or dye-spray chromoendoscopy7 or add-on device such as Cap/Endocuff/third eye/FUSE-assisted endoscopy8. Among them, some had showed the potential to enhance the detection of non-polypoid lesion, for example, the next-generation NBI9 or iSCAN10.

Application of 3D endoscopy on GI disease: 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 tumors11 and shortened the procedure time during performing gastric endoscopic submucosal dissection (ESD)12. However, few is known that whether 3D colonoscopy could enhance the ADR, especially for non-polypoid lesion detection, during colonoscopy examination.

Positive fecal immunochemical test(FIT) group Among subjects who receive colonoscopy examination, higher advanced adenoma or invasive caners were found in FIT positive group. However, still about half of positive FIT subjects who received colonoscopy exam, have negative colonoscopy result. Non polypoid lesions could be overlooked during the colonoscopy. Therefore, we tried to use this prospective, multicenter, randomized control study to demonstrate the efficacy of 3D colonoscopy on adenoma detection in comparison with conventional 2D colonoscopy in this kind of high risk group.


Eligibility criteria: Inclusion Criteria:

* Subjects who are 40 years of older
* Subjects who have positive fecal immunochemical test

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

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 30 minutes
Secondary outcomes:
measure: Flat-ADR
timeFrame: 30 minutes
measure: Proximal ADR
timeFrame: 30 minutes
measure: SSLDR
timeFrame: 30 minutes
measure: AADR
timeFrame: 30 minutes
measure: Polyp detection rate
timeFrame: 30 minutes
measure: adenoma number per colonoscopy,
timeFrame: 30 minutes
measure: polyp number per colonoscopy,
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Hsin-Chu
country: Taiwan
facility: National Taiwan University Hospital, Hsinchu Branch
city: Taipei
country: Taiwan
facility: National Taiwan University Cancer Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: