Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital Augsburg | OTHER |
| Changi General Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
The investigators hypothesize that the combined use of CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) would improve the adenoma detection rate when compared to CADe system alone.
High polyp miss rates were reported in standard colonoscopies. As a result, a significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy. Risk factors of missed lesions included proximal location, serrate or flat morphology, poor bowel preparation, short withdrawal time and endoscopist experience.
To overcome this pitfall, various methods were developed to improve adenoma detection rate (ADR), including distal attachment devices. Among the mucosal exposure devices, Endocuff Vision® was shown to be superior than conventional colonoscopies.
Recently, artificial intelligence and automatic computer-aided polyp detection (CADe) systems have developed rapidly and revolutionized the medical field. Nevertheless, there was a potential limitation of 'blind spot' if the endoscopist failed to expose the colonic mucosa adequately leading to missed lesions. To date, no available data or ongoing clinical trial was reported regarding the combined use of CADe and mucosal exposure devices. It may enhance the performance of CADe and provide a novel definitive solution to this unaddressed yet important clinical problem.
In this prospective parallel randomized controlled trial, we aim to evaluate the impact of combined use of a new CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) on colorectal neoplasia detection.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENDOAID | No Intervention | CADe system will be used during withdrawal phase of colonoscopy. | |
| ENDOAID with ENDOCUFF | Experimental | CADe system and mucosal exposure device (ENDOCUFF) will be used during withdrawal phase of colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDOCUFF | Device | ENDOCUFF mucousal exposure device will be used during withdrawal process of the colonoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ADR | adenoma detection rate | During the colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| ADR for adenomas of different sizes | <5mm, 5-10mm, >10mm | During the colonoscopy |
| ADR for adenomas of different colonic segments | caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Shatin | Hong Kong Island | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007414 | Intestinal Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| During the colonoscopy |
| Mean number of adenomas per colonoscopy | Mean number of adenomas per colonoscopy | During the colonoscopy |
| Advanced adenoma detection rate | Advanced adenoma detection rate | During the colonoscopy |
| Sessile serrated lesion (SSL) detection rate | Sessile serrated lesion (SSL) detection rate | During the colonoscopy |
| Polyp detection rate | Polyp detection rate | During the colonoscopy |
| Non-neoplastic resection rate | defined as absence of adenoma or SSL or cancer within resected specimen | During the colonoscopy |
| Caecal intubation time | Caecal intubation time | During the colonoscopy |
| Withdrawal time | excluding interventions | During the colonoscopy |
| Total procedural time | Total procedural time | During the colonoscopy |
| False positive rate | defined as computer artifacts due to colonic mucosal wall or bowel content lasting for >2 seconds | During the colonoscopy |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |