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Can Artificial Intelligence detect and improve the Upper Gastrointestinal Cancer During Endoscopy

A Multicenter Randomized Controlled Trial Evaluating AI-Assisted High Definition White Light Endoscopy versus Standard High Definition White Light Endoscopy for Upper Gastrointestinal Malignancy Detection - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113740
Enrollment
2400
Registered
2026-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: K319- Disease of stomach and duodenum, unspecified

Interventions

Intervention1: AI-assisted endoscopy: In AI-assisted examinations, lesions will be identified by stable red-box markings generated by AI model Control Intervention1: Standard high-definition white-lig

Sponsors

Department of Gastroenterology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age more than or equal to 18 years 2 Individuals undergoing upper gastrointestinal endoscopy who are either symptomatic with upper gastrointestinal complaints and or apparently healthy individuals presenting with high risk alarm features including a Loss of appetite b Unintentional weight loss less than or equal to 5 percent of body weight in the past 3 months c Anemia as per WHO criteria hemoglobin less than or equal to 13 g per dL in men and less than 12 g per dL in women d Family history of UGI malignancy e Diets high in salted smoked and pickled foods f Prior history of Helicobacter pylori infection or related atrophic gastritis and Barretts esophagus 3 Willingness to provide informed consent

Exclusion criteria

Exclusion criteria: 1 Prior diagnosis of UGI malignancy 2 History of previous major surgery altering anatomy 3 Absolute contraindications to upper GI endoscopy 4 Contraindications to biopsy 5 Pregnancy and Lactating mothers 6 Unwilling to provide written informed consent

Design outcomes

Primary

MeasureTime frame
1 To compare the missing rate of upper gastrointestinal malignancies between AI assisted HD WLE and standard HD WLE 2 To compare the diagnostic yield per biopsy between AI assisted HD WLE and standard HD WLE Timepoint: Baseline

Secondary

MeasureTime frame
1 To compare the UGI malignancies detection rate between AI assisted HD WLE and standard HD WLE. 2 To compare biopsy rates between AI assisted HD WLE and standard HD WLE. 3 To compare the mean number of neoplastic lesions detected per patient between AI-assisted HD WLE and standard HD WLE. 4 To compare the patient-level missing rate of UGI malignancies between AI-assisted HD WLE and standard HD WLE. 5 To determine and compare the positive predictive value of neoplastic lesion identification between AI assisted HD WLE and standard HD WLE. 6 To compare the total diagnostic observation time between AI assisted HD WLE and standard HD WLE. Timepoint: Baseline

Countries

India

Contacts

Public ContactVineet Ahuja

All India Institute of Medical Sciences, New Delhi

vineet.aiims@gmail.com09810707170

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026