NCT06066372

Brief Summary

Machine learning predictive model can help in stratifying heterogenous intermediate likelihood group to reduce need for EUS or MRCP in selected subgroup of patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Oct 2023Oct 2026

First Submitted

Initial submission to the registry

September 13, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

September 13, 2023

Last Update Submit

January 4, 2026

Conditions

Choledocholithiasis

Outcome Measures

Primary Outcomes (1)

  • Area Under the Receiver Operating Characteristic Curve (AUROC) of the Machine Learning Model

    Area under the receiver operating characteristic curve (AUROC) of the machine learning-based prediction model for identifying the presence of choledocholithiasis.

    1 month

Secondary Outcomes (2)

  • Diagnostic Accuracy Metrics of Endoscopic Ultrasound (EUS) or Magnetic Resonance Cholangiopancreatography (MRCP)

    1 Month

  • Validation Performance of the Machine Learning Prediction Model

    1 Month

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with suspected choledocholithiasis satisfying either ESGE or ASGE risk stratification criteria of intermediate likelihood of choledocholithiasis will be prospectively enrolled from AIG Hospitals, Hyderabad

You may qualify if:

  • Individual 18 years or older with a suspected choledocholithiasis satisfying either ASGE or ESGE risk stratification criteria of intermediate likelihood undergoing EUS or MRCP

You may not qualify if:

  • Patients having co-exiting disease of pancreato biliary system other than gall stones and choledocholithiasis which include chronic pancreatitis, biliary stricture, pancreatobiliary malignancy, portal biliopathy
  • Patients having underlying chronic liver diseases
  • Pregnancy and breast feeding
  • Previous history of cholecystectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500032, India

RECRUITING

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasis

Study Officials

  • Mohan Ramchandani, MD

    Asian Institute of Gastroenterology

    STUDY DIRECTOR

Central Study Contacts

Nitin G Jagtap, MD

CONTACT

+919182859523docnits13@gmail.com

Hardik Rughwani, MD

CONTACT

+919182859523hardik.hr@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 4, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

January 6, 2026

Record last verified: 2025-12

Locations

IN(1)