Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07818317

Prospective Study of an Explainable AI Tool to Support Biliopancreatic Limb Selection in One-Anastomosis Gastric Bypass

Sponsor: The Society of Bariatric and Metabolic Surgeons of Kazakhstan

View on ClinicalTrials.gov

Summary

This prospective observational cohort study will develop and externally validate a human-supervised, explainable artificial-intelligence decision-support model for analysing factors associated with biliopancreatic limb length selection during one-anastomosis gastric bypass (OAGB). The study will record three prespecified factors: the percentage of the laparoscopic instrument segment J-I covered by visceral or omental fat (P\_JI = 100 × FI/JI), the measured total small-bowel length (TSBL), and the abdominal integral index (AII = (CD/AC) + (CG/EG) + (JI/FI)). The study will evaluate weight-loss effectiveness, nutritional and malabsorptive outcomes, bile/acid reflux, major complications, and technical feasibility. During model development, the AI system will not autonomously assign a BPL length. The operating bariatric surgeon will make the clinical decision, and the model will be evaluated for calibration, external validity, factor contribution, safety constraints, and abstention.

Official title: A Study Protocol for Multivariable Regression and Explainable Artificial Intelligence to Support Biliopancreatic Limb Selection in One-Anastomosis Gastric Bypass Using J-I Fat Coverage, Total Small-Bowel Length, and AII

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2027-01-15

Completion Date

2029-11-01

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

PROCEDURE

One-anastomosis gastric bypass with observed biliopancreatic limb length

Participants undergo primary laparoscopic or robot-assisted one-anastomosis gastric bypass as part of routine clinical care. The observed biliopancreatic limb length, operative configuration, surgical platform, centre, and surgeon are recorded. During model development, the study does not assign a BPL length and the AI system does not replace the surgeon's clinical judgment. Candidate lengths of 0.5, 1, 2, and 3 m are research-action labels used to evaluate predictions and safety constraints, not automatically assigned treatment arms. Additional exposure variables: * P\_JI (%) = 100 × FI/JI * TSBL in centimetres * AII = (CD/AC) + (CG/EG) + (JI/FI) * Residual absorptive bowel after observed BPL length * Surgical platform: laparoscopic or robot-assisted * Centre and surgeon identifier * Operative configuration and reflux-prevention technique

Locations (1)

Oral Ospanov

Astana, Aqmola, Kazakhstan