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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAsian Institute of Gastroenterology, India

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial 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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Other outcomes

Sponsors and contacts

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