Colorectal Cancer, Colorectal Neoplasms
Conditions
Keywords
3D Colonoscopy, Colorectal neoplasm
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.
Interventions
DEVICE3D colonoscopy
3D colonoscopy is a new device to enhance endoscopic imaging.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
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.)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | 1 week | The number of subjects with at least one adenomatous polyp found during the colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proximal adenoma detection rate | 1 weeks | The number of subjects with at least one adenomatous polyp found at proximal colon ( cecum, ascending colon and hepatic flexure) during the colonoscopy |
| Sessile serrated adenoma detection rate | 1 week | The number of subjects with at least one sessile serrated adenomatous polyp found during the colonoscopy |
| Adenoma per colonoscopy (APC) | 1 week | Average adenomatous polyps number found in each colonoscopy |
| Flat adenoma detection rate | 1 week | The number of subjects with at least one flat adenomatous polyp found during the colonoscopy |
Countries
Taiwan
Outcome results
None listed