To Compare EUS and MRCP in Detecting Choledocholithiasis in Patients of Intermediate Risk of Choledocholithiasis
Condition: Choledocholithiasis
MeSH terms: Choledocholithiasis
Study type: Interventional

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 .
    

Intervention name(s): Endosonography; Magnetic Resonance Cholangiopancreatography
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Endosonography (EUS) is endoscopic method for evaluated pancreatic and biliary pathology.; Magnetic Resonance Cholangiopancreatography (MRCP) is non-invasive method for evaluating pancreatic and biliary pathology
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: EUS; MRCP; Intermediate Probability