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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04173624
Recruitment Status : Completed
First Posted : November 22, 2019
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Rakesh K, Asian Institute of Gastroenterology, India

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.

Condition or disease Intervention/treatment Phase
Choledocholithiasis Diagnostic Test: Endosonography Diagnostic Test: Magnetic Resonance Cholangiopancreatography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Endosonography Versus Magnetic Resonance Cholangiopancreatography for Choledocholithiasis for Intermediate Risk of Choledocholithiasis (as Per European Society of Gastrointestinal Endoscopy Guidelines )- Randomized Controlled Trial
Actual Study Start Date : December 3, 2019
Actual Primary Completion Date : July 28, 2020
Actual Study Completion Date : July 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy MRI Scans

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173624


Locations
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India
Asian Institute of Gastroenterology
Hyderabad, Telangana, India, 500082
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rakesh K, Consultant Gastroenterologist, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT04173624    
Other Study ID Numbers: EUS Vs MRCP-01
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rakesh K, Asian Institute of Gastroenterology, India:
EUS
MRCP
Intermediate Probability
Additional relevant MeSH terms:
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Choledocholithiasis
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis