Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of the study to evaluate the usefulness of the Endo-AID artificial intelligence system in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy.
The secondary aims were:
Priority guidelines have been established regarding IA applied to gastrointestinal endoscopy. Regarding the priority uses for their development, there are applications that improve vision, placing computer-assisted lesion detection (CADe) as one of the most necessary priorities, given the importance of colorectal cancer screening (CRC) and post-polypectomy surveillance. The evaluation of these systems in different clinical practices and patient groups has been recommend. In this regard, studies in the western population are limited and have been carried out by expert endoscopists. It has not been evaluated in endoscopists with different adenoma detection rates. In addition, there are no studies with the recent CADe Endo-AID system (Olympus Corp. Tokyo).
The main purpose of the study to evaluate the usefulness of the Endo-AID artificial intelligence system in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy. In addition, the benefit of the CADe system will be assessed according to the endoscopist ADR.
A randomized controlled trial will be carried out in consecutive outpatients meeting the inclusion criteria and none of the exclusion criteria. Patients with be randomized to one of the four groups: CADe system and high ADR endoscopist; CADe system and low ADR endoscopist; Control and high ADR endoscopist; Control and low ADR endoscopist.
For the sample size calculation a 14.4 of difference in favor of the CADe system was considered. Taking onto account an alpha error of 0.05 in a unilateral contrast, a power of 80% and a loss of 10%, 165 patients per group would be required.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computed adenoma detection system (CADe) | Experimental | Tis system can detect in the screen suspicion areas of adenomatous polyps. This is an additional help for the endoscopist for the detection of lesions |
|
| Control group (absence of CADe) | Active Comparator | This is the control group. As in the routine colonoscopy the endoscopist is in charge of the detection of the lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed adenoma detection system (CADe) | Device | This is a computed system that helps the endoscopist to increase the detection of colorectal polyps |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate | Number of colonoscopies with colorectal adenoma/Number of total colonoscopies | [Time frame: 1 years][Designated as safety issue: No] |
| Measure | Description | Time Frame |
|---|---|---|
| Serrated detection rate | Number of colonoscopies with serrated adenoma/Number of total colonoscopies | [Time Frame: 1 years][Designated as safety issue: No] |
| Advanced adenoma detection rate | Number of colonoscopies with advanced adenoma/Number of total colonoscopies |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antonio Gimeno Garcia, MD, PhD | Hospital Universitario de Canarias | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology | San Cristóbal de La Laguna | S/C de Tenerife | 38320 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32598963 | Background | Hassan C, Spadaccini M, Iannone A, Maselli R, Jovani M, Chandrasekar VT, Antonelli G, Yu H, Areia M, Dinis-Ribeiro M, Bhandari P, Sharma P, Rex DK, Rosch T, Wallace M, Repici A. Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis. Gastrointest Endosc. 2021 Jan;93(1):77-85.e6. doi: 10.1016/j.gie.2020.06.059. Epub 2020 Jun 26. | |
| 32565188 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control group (regular colonoscopy) | Behavioral | It is exclusively the endoscopist in charge of the detection of the polyps (usual practice) |
|
| [Time Frame: 1 years][Designated as safety issue: No] |
| Result |
| Berzin TM, Parasa S, Wallace MB, Gross SA, Repici A, Sharma P. Position statement on priorities for artificial intelligence in GI endoscopy: a report by the ASGE Task Force. Gastrointest Endosc. 2020 Oct;92(4):951-959. doi: 10.1016/j.gie.2020.06.035. Epub 2020 Jun 19. |
| 31981517 | Result | Wang P, Liu X, Berzin TM, Glissen Brown JR, Liu P, Zhou C, Lei L, Li L, Guo Z, Lei S, Xiong F, Wang H, Song Y, Pan Y, Zhou G. Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):343-351. doi: 10.1016/S2468-1253(19)30411-X. Epub 2020 Jan 22. |
| 32562721 | Result | Wang P, Liu P, Glissen Brown JR, Berzin TM, Zhou G, Lei S, Liu X, Li L, Xiao X. Lower Adenoma Miss Rate of Computer-Aided Detection-Assisted Colonoscopy vs Routine White-Light Colonoscopy in a Prospective Tandem Study. Gastroenterology. 2020 Oct;159(4):1252-1261.e5. doi: 10.1053/j.gastro.2020.06.023. Epub 2020 Jun 17. |
| 36228695 | Derived | Gimeno-Garcia AZ, Hernandez Negrin D, Hernandez A, Nicolas-Perez D, Rodriguez E, Montesdeoca C, Alarcon O, Romero R, Baute Dorta JL, Cedres Y, Castillo RD, Jimenez A, Felipe V, Morales D, Ortega J, Reygosa C, Quintero E, Hernandez-Guerra M. Usefulness of a novel computer-aided detection system for colorectal neoplasia: a randomized controlled trial. Gastrointest Endosc. 2023 Mar;97(3):528-536.e1. doi: 10.1016/j.gie.2022.09.029. Epub 2022 Oct 11. |
| D008722 | Methods |