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NCT06385860 Clinical Trial

Prediction Model for Early Biliary Stasis After Bariatric Surgery

Obesity Clinical Trial

— PM-EBS-BS  

Official title:
Research on the Prediction Model for Early Biliary Stasis After Bariatric Surgery Based on Machine Learning Algorithms

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06385860
Other study ID # GTMGS0423
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2024
Est. completion date April 2025

Study information
Verified date April 2024
Source China-Japan Friendship Hospital
Contact siqi Wang
Phone 8618810315722
Email wsqi@pku.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery

Description:

This study aims to create and validate a model that predicts the likelihood of early biliary stasis in obese patients following bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass)

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date April 2025
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. BMI =32.5 kg/m2 with one or more obesity-related comorbidities. 2. BMI >35 kg/m2 without coexisting medical problems 3. complete preoperative and follow-up data. Exclusion Criteria: 1. other bariatric procedures. 2. contraindications for bariatric surgery.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
China-Japan Friendship Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary early biliary stasis The incidence of early biliary stasis after bariatric surgery one month
Primary prediction model Area under the curve (AUC) of the prediction model six months
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