To Compare EUS and MRCP in Detecting Choledocholithiasis in Patients of Intermediate Risk of Choledocholithiasis

NCT04173624 | Completed DMC

• 1 other identifier: EUS Vs MRCP-01
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

A Recent Meta analysis, showed pooled sensitivity and specificity were 97% and 90 for EUS and 87% and 92 for MRCP . This meta analysis includes only 5 studies, smaller sample size in each study, significant heterogeneity in reference standards ranged from ERCP and Intra operative cholangiography (IOC) to clinical follow up for negative patients . Furthur validation of EUS Vs MRCP is needed in detecting common bile duct caliculi in intermediate risk of choledocholithiasis To date Randamized control trail comparing EUS Vs MRCP in detecting Choledocholithiasis lacking , hence the investigators aimed a Randamized control trail determining and comparing the sensitivity and specificity of EUS and MRCP in diagnosing Choledocholithiasis.

Conditions

Choledocholithiasis

Keywords

EUS; MRCP; Intermediate Probability

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of EUS Vs MRCP

  This study will evaluate diagnostic accuracy of MRCP and EUS in patients with intermediate probability of choledocholithiasis as per European society of GI endoscopy guidelines

  4 month

Secondary Outcomes (3)

• Rate of Adverse Events

  4 month

• Cost - Effectiveness

  4 months

• Rate of Additional Significant Endoscopic finding

  4 months

Study Arms (2)

Endosonography

EXPERIMENTAL

Endosonography is endoscopic method to diagnose pancreatic and biliary disorders. Participants randomized to this arm will undergo diagnostic endosonography under propofol sedation in supervision of trained anesthesiologists. If choledocholithiasis is diagnosed on endosonography, patient will be subjected for endoscopic retrograde cholangiopancreatography for clearance of stone. If choledocholithiasis is not present then participants will be kept in follow-up and further evaluation will be done if clinically indicated as per discretion of treating physician.

Diagnostic Test: Endosonography

Magnetic Resonance Cholangiopancreatography

EXPERIMENTAL

Magnetic Resonance Cholangiopancreatography (MRCP) is non-invasive method for diagnosis of pancreatic and biliary disorders. Participants randomized to this arm will undergo MRCP. If choledocholithiasis is diagnosed on MRCP, participants will be subjected for endoscopic retrograde cholangiopancreatography for clearance of stone. If choledocholithiasis is not present then participants will be kept in follow-up and further evaluation will be done if clinically indicated as per discretion of treating physician.

Diagnostic Test: Magnetic Resonance Cholangiopancreatography

Interventions

Endosonography DIAGNOSTIC_TEST

Endosonography (EUS) is endoscopic method for evaluated pancreatic and biliary pathology.

Endosonography

Magnetic Resonance Cholangiopancreatography DIAGNOSTIC_TEST

Magnetic Resonance Cholangiopancreatography (MRCP) is non-invasive method for evaluating pancreatic and biliary pathology

Magnetic Resonance Cholangiopancreatography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18yrs of age with suspected choledocholithiasis stratified into intermediate risk of choledocholithiasis as per European Society of Gastrointestinal Endoscopy Guidelines

You may not qualify if:

• Patients with Cholangitis
• Patients with hypotension
• Ultrasound or CT cross sectional image showing stone
• Patients with contraindications to MRCP (claustrophobia ,pacemaker, or any prosthesis contraindicating MR)
• Predictable impossibility to perform a complete exploration of pancreato biliary area by EUS (gastroenteroanastomosis or stenosis )
• Patients with suspected pancreato biliary malignancy or pancreato biliary malformations
• Patients with history significant alcohol intake
• Patients taking hepato toxic drugs
• Patients in whom serum hepatitis B or C antibodies are present
• Patients with confirmed history of choledocholithiasis or history of biliary sphincterotomy
• Patients not giving consent for participation

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

Location

Related Publications (1)

• Jagtap N, Kumar JK, Chavan R, Basha J, Tandan M, Lakhtakia S, Kalapala R, Nabi Z, Gupta R, Ramchandani M, Talukdar R, Reddy M, Yarlagadda R, Singh J, Memon SF, Venkat Rao G, Reddy DN. EUS versus MRCP to perform ERCP in patients with intermediate likelihood of choledocholithiasis: a randomised controlled trial. Gut. 2022 Feb 10:gutjnl-2021-325080. doi: 10.1136/gutjnl-2021-325080. Online ahead of print.

  PMID: 35144973 DERIVED

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Endosonography; Cholangiopancreatography, Magnetic Resonance

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Digestive System

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 22, 2019
• Study Start: December 3, 2019
• Primary Completion: July 28, 2020
• Study Completion: July 28, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

IN (1)