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

Study Overview
=================
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 .

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

Conditions
-----------------
Choledocholithiasis

Intervention / Treatment
-----------------
* Diagnostic Test: Endosonography
* Diagnostic Test: Magnetic Resonance Cholangiopancreatography


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EUS, MRCP, Intermediate Probability