Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: AI-assisted IBD surveillance colonoscopy: In the intervention arm, a deep-learning computer-aided detection (CADe) system will be used to
assist real-time dysplasia detection. The syste
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 years. 2. Confirmed diagnosis of ulcerative colitis. 3. Scheduled for routine surveillance colonoscopy according to established guidelines (typically disease duration greater than or equal to 8 10 years, or earlier in the presence of primary sclerosing cholangitis). 4. Capable of providing informed consent and willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. History of colorectal neoplasia, including prior dysplasia or colorectal cancer 2. Patients with Crohn s colitis 3. Previous colectomy or proctocolectomy. 4. Active severe colitis, or hospitalization for a severe flare within the preceding 4 weeks. 5. Presence of a hereditary or established polyposis syndrome. 6. Pregnant, lactating females 7. Any contraindication to colonoscopy or mucosal biopsy, including cardiopulmonary instability or bleeding disorders not correctable before the procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Per-patient Dysplasia Detection Rate (DDR): Defined as the proportion of participants in whom at least one histologically confirmed dysplastic lesion (of any grade) is identified during the index colonoscopy.Timepoint: baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean number of histology-confirmed dysplastic lesions detected per colonoscopy. 2. Proportion of patients with high-grade dysplasia (HGD) or colorectal cancer (CRC). 3. Detection proportion of lesions that are diminutive (less than or equal to 5 mm), flat, or located in anatomically challenging segments (e.g., cecum or ascending colon). 4. Number of system-generated alerts that do not correspond to a true dysplastic lesion, expressed as false positives per colonoscopy. 5. Withdrawal time (total & excluding biopsy time), insertion time, & overall procedure duration.Timepoint: baseline | — |
Countries
India
Contacts
Public ContactDr Vineet Ahuja
AIIMS New Delhi
Outcome results
None listed