Discovery II Study

Discovery: Pentax’ Computer-aided Detection to Improve Adenoma Detection in a Real-time Setting. The Discovery II Study - A randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22821

Enrollment

560

Registered

2020-12-21

Start date

2021-01-04

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal carcinoma, colorectal polyps, colorectal adenomas

Interventions

Usage of Pentax Discovery Computer Aided Detection System.

Eligibility

Inclusion criteria

Inclusion criteria: - = 18 years; - Referred and scheduled for diagnostic, screening (non-iFOBT based) or surveillance colonoscopy.

Exclusion criteria

Exclusion criteria: - Known colorectal tumor or polyp on referral; - Referral for a therapeutic procedure (i.e. endoscopic resection, intervention for lower gastro-intestinal bleeding, etc.); - Inadequately corrected anticoagulation disorders or anticoagulation medication use; - American Society of Anesthesiologists (ASA) score ? 3; - Inability to provide informed consent; - Known or suspected inflammatory bowel disease.

Design outcomes

Primary

Measure	Time frame
Adenoma detection rate (ADR)	—

Secondary

Measure	Time frame
- The PDR (calculated as the number of patients in whom at least one polyp is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure (e.g. PCSC or CC); - The mean number of adenomas detected per patient; - The mean number of polyps detected per patient; - The number of sessile serrated lesions; - The number of advanced adenomas (i.e. adenomas = 10 mm and/or harbouring a villous component and/or containing HGD; - Size of the lesion; 0-5 mm, 6-10 mm, 10-20 mm, >20 mm - Location of the lesion; Caecum, ascending, transverse, descending, sigmoid, rectum - Morphological characteristics of the lesion using the Paris classification18; Ip, Is, IIa, IIb, IIc, III - Histopathological characteristics of the lesion according to the Vienna classification19; - The ADR of the first 20% of patients scoped by each endoscopist will be compared with the final 20% of patients in each arm to identify any changes in ADR throughout the trial; - Bowel cleansing levels using the BBPS20; - Procedure times with both techniques (i.e. total procedure time, mean polypectomy time and withdrawal time); - (Severe) adverse events up to 30 days post-procedure; - Post-colonoscopy surveillance intervals when applying European and US surveillance guidelines; - The number of false positives; - The reason why a notification is assessed as false positive by the endoscopist (i.e. bubbles, fecal material, etc.); - The number of false negatives.	—

Measure

Time frame

- The PDR (calculated as the number of patients in whom at least one polyp is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure (e.g. PCSC or CC); - The mean number of adenomas detected per patient; - The mean number of polyps detected per patient; - The number of sessile serrated lesions; - The number of advanced adenomas (i.e. adenomas = 10 mm and/or harbouring a villous component and/or containing HGD; - Size of the lesion; 0-5 mm, 6-10 mm, 10-20 mm, >20 mm - Location of the lesion; Caecum, ascending, transverse, descending, sigmoid, rectum - Morphological characteristics of the lesion using the Paris classification18; Ip, Is, IIa, IIb, IIc, III - Histopathological characteristics of the lesion according to the Vienna classification19; - The ADR of the first 20% of patients scoped by each endoscopist will be compared with the final 20% of patients in each arm to identify any changes in ADR throughout the trial; - Bowel cleansing levels using the BBPS20; - Procedure times with both techniques (i.e. total procedure time, mean polypectomy time and withdrawal time); - (Severe) adverse events up to 30 days post-procedure; - Post-colonoscopy surveillance intervals when applying European and US surveillance guidelines; - The number of false positives; - The reason why a notification is assessed as false positive by the endoscopist (i.e. bubbles, fecal material, etc.); - The number of false negatives.

—

Contacts

Public ContactElsa Soons

Radboudumc

elsa.soons@radboudumc.nl0650000996

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)