Choledocholithiasis Clinical Trial
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
Verified date | August 2020 |
Source | Asian Institute of Gastroenterology, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 228 |
Est. completion date | July 28, 2020 |
Est. primary completion date | July 28, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
India | Asian Institute of Gastroenterology | Hyderabad | Telangana |
Lead Sponsor | Collaborator |
---|---|
Asian Institute of Gastroenterology, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 4 month | |
Secondary | 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. | 4 months | |
Secondary | 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. | 4 months |
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