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

Primary Purpose

Choledocholithiasis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Endosonography
Magnetic Resonance Cholangiopancreatography
Sponsored by
Asian Institute of Gastroenterology, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Choledocholithiasis focused on measuring EUS, MRCP, Intermediate Probability

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Asian Institute of Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Endosonography

Magnetic Resonance Cholangiopancreatography

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Adverse Events
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.
Cost - Effectiveness
Cost benefits analysis for EUS Vs MRCP will be done for detection of choledocholithiasis by using total cost along with direct and indirect cost.
Rate of Additional Significant Endoscopic finding
In Endosonography arm, total additional endoscopic clinically significant findings such as ulcer, polyps, esophageal and gastric varies, gastric outlet obstruction will be collected.

Full Information

First Posted
November 19, 2019
Last Updated
August 17, 2020
Sponsor
Asian Institute of Gastroenterology, India
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1. Study Identification

Unique Protocol Identification Number
NCT04173624
Brief Title
To Compare EUS and MRCP in Detecting Choledocholithiasis in Patients of Intermediate Risk of Choledocholithiasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
July 28, 2020 (Actual)
Study Completion Date
July 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asian Institute of Gastroenterology, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis
Keywords
EUS, MRCP, Intermediate Probability

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endosonography
Arm Type
Experimental
Arm Description
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.
Arm Title
Magnetic Resonance Cholangiopancreatography
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Endosonography
Intervention Description
Endosonography (EUS) is endoscopic method for evaluated pancreatic and biliary pathology.
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance Cholangiopancreatography
Intervention Description
Magnetic Resonance Cholangiopancreatography (MRCP) is non-invasive method for evaluating pancreatic and biliary pathology
Primary Outcome Measure Information:
Title
Sensitivity and Specificity of EUS Vs MRCP
Description
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
Time Frame
4 month
Secondary Outcome Measure Information:
Title
Rate of Adverse Events
Description
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.
Time Frame
4 month
Title
Cost - Effectiveness
Description
Cost benefits analysis for EUS Vs MRCP will be done for detection of choledocholithiasis by using total cost along with direct and indirect cost.
Time Frame
4 months
Title
Rate of Additional Significant Endoscopic finding
Description
In Endosonography arm, total additional endoscopic clinically significant findings such as ulcer, polyps, esophageal and gastric varies, gastric outlet obstruction will be collected.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500082
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
35144973
Citation
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.
Results Reference
derived

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

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