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