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

August 17, 2020 updated by: Rakesh K, Asian Institute of Gastroenterology, India

Endosonography Versus Magnetic Resonance Cholangiopancreatography for Choledocholithiasis for Intermediate Risk of Choledocholithiasis (as Per European Society of Gastrointestinal Endoscopy Guidelines )- Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim: Endosonography Versus Magnetic Resonance Cholangiopancreatography for Choledocholithiasis for Intermediate Risk of Choledocholithiasis (as Per European Society of Gastrointestinal Endoscopy Guidelines )- Randomized Controlled Trial

Outcomes

A.Primary Outcome :

•Sensitivity and Specificity of EUS Vs MRCP

B.Secondary Outcomes:

  • Cost effectiveness
  • Adverse effects
  • Additional Clinically Significant endoscopic findings

MATERIAL AND METHODS Study area •out-patients and in-patients in Asian Institute of Gastroenterology Study design Randamized control study Study period November 2019-March 2020

INCLUSION CRITERIA:

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

Exclusion criteria:

  • 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

STUDY PROCEDURE The study will be a Randomized control study where sensitivity and specificity and secondary outcomes - cost effectiveness, adverse effects will be compared between EUS and MRCP group . All the patients presented to outpatient department or in patient wards with suspected choledocholithiasis will be screened as per European Society of Gastrointestinal Endoscopy guideline. Patients stratified into intermediate probability will be selected based on inclusion and exclusion criteria. Then patients will randomized to either EUS or MRCP based computerized software .Patients who are randomized to EUS group will undergo EUS for detection of Choledocholithiasis and then undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) at same time if calculi detected and patients in whom calculi was not found, management is based on clinical judgement and 3months follow up . Patients who are randomized to MRCP group will undergo MRCP for detection of Choledocholithiasis and then undergo ERCP if calculi detected. Patients in whom calculi was not found, management will be based on clinical judgement and 3 months follow up. Based on presence of or absence of stone in Reference standard i.e in ERCP following EUS or MRCP or during 3 month follow up , sensitivities and specificities of EUS and MRCP are calculated and compared .

Study Type

Interventional

Enrollment (Actual)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Asian Institute of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endosonography
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
Endosonography (EUS) is endoscopic method for evaluated pancreatic and biliary pathology.
Experimental: Magnetic Resonance Cholangiopancreatography
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
Magnetic Resonance Cholangiopancreatography (MRCP) is non-invasive method for evaluating pancreatic and biliary pathology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of EUS Vs MRCP
Time Frame: 4 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Adverse Events
Time Frame: 4 month
Adverse events related with EUS and MRCP will be collected. Those who undergo ERCP for choledocholithiasis, total adverse events related to ERCP will be collected.
4 month
Cost - Effectiveness
Time Frame: 4 months
Cost benefits analysis for EUS Vs MRCP will be done for detection of choledocholithiasis by using total cost along with direct and indirect cost.
4 months
Rate of Additional Significant Endoscopic finding
Time Frame: 4 months
In Endosonography arm, total additional endoscopic clinically significant findings such as ulcer, polyps, esophageal and gastric varies, gastric outlet obstruction will be collected.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2019

Primary Completion (Actual)

July 28, 2020

Study Completion (Actual)

July 28, 2020

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUS Vs MRCP-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Choledocholithiasis

Clinical Trials on Endosonography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe