ClinicalTrials.gg
RecruitingNCT06066372Updated Jan 6, 2026

Application of Machine Learning Models to Reduce Need for Diagnostic EUS or MRCP in Patients With Intermediate Likelihood of Choledocholithiasis

An observational study in Choledocholithiasis, sponsored by Asian Institute of Gastroenterology, India. Recruiting at 1 site in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Asian Institute of Gastroenterology, India · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

The current guidelines for suspected choledocholithiasis are aimed to reduce the risk of patient receiving diagnostic ERCP and reduce the risk of post ERCP adverse events. In this process there is apparent increase in number of patients in the intermediate likelihood group requiring EUS or MRCP. This can increase the health care utilization and cost of care for intermediate likelihood patients. The field of artificial intelligence in clinical medicine is evolving rapidly. The use of artificial intelligence based machine learning model is not adequately studied for prediction of choledocholithiasis. Machine learning predictive model can help in stratifying heterogenous intermediate likelihood group to reduce need for EUS or MRCP in selected subgroup of patients.

02

Conditions studied

  • Choledocholithiasis

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03

In context

Choledocholithiasis

109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 31 observational studies indexed under Choledocholithiasis.

Browse Choledocholithiasis studies →

Lead sponsor

Asian Institute of Gastroenterology, India is the lead sponsor of 135 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Probability 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients having co-exiting disease of pancreato biliary system other than gall stones and choledocholithiasis which include chronic pancreatitis, biliary stricture, pancreatobiliary , portal biliopathy
  • Patients having underlying chronic liver diseases
  • Pregnancy and breast feeding
  • Previous history of cholecystectomy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: 1 month

Secondary outcomes

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

    Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUROC) of magnetic resonance cholangiopancreatography (MRCP) for identification of choledocholithiasis.

    Time frame: 1 Month

  2. Validation Performance of the Machine Learning Prediction Model

    Validation performance of the machine learning model for predicting choledocholithiasis, assessed using AUROC, calibration metrics (Brier score), and calibration plots in an independent validation cohort.

    Time frame: 1 Month

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2023 (actual). Primary completion is estimated for Jun 2026, 32 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2023
First posted
Oct 4, 2023
StartActual
Oct 1, 2023
Primary completionEst.
Jun 30, 2026
CompletionEst.
Oct 30, 2026
Last update
Jan 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06066372
Responsible party
Sponsor
First posted
Oct 4, 2023
Start date
Oct 1, 2023
Primary completion
Jun 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Jan 6, 2026

Study contacts

Nitin G Jagtap, MD
Contact
docnits13@gmail.com
+919182859523
Hardik Rughwani, MD
Contact
hardik.hr@gmail.com
+919182859523
Mohan Ramchandani, MD
study director · Asian Institute of Gastroenterology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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