Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D device.
- Who it may be relevant to
- Registry conditions: Adenoma Detection Rate, Colonoscopy, Three Dimensional, Fecal Immunochemical Test. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group: a Multi-center, Randomized Controlled Trial
Overview
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.
Interventions
- Device 3D device
Use 3D machine to generate the 3D image
Primary outcome measures
- Adenoma detection rate [Time frame: 30 minutes]
Secondary outcome measures (7)
- Flat-ADR [Time frame: 30 minutes]
- Proximal ADR [Time frame: 30 minutes]
- SSLDR [Time frame: 30 minutes]
- AADR [Time frame: 30 minutes]
- Polyp detection rate [Time frame: 30 minutes]
- adenoma number per colonoscopy, [Time frame: 30 minutes]
- polyp number per colonoscopy, [Time frame: 30 minutes]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
Taiwan · 3 centers
- National Taiwan University Hospital, Hsinchu Branch — Hsinchu
- National Taiwan University Cancer Center — Taipei
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT06678477 · 202311028DIPA