Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis (STONE)
Choledocholithiasis
About this trial
This is an interventional diagnostic trial for Choledocholithiasis
Eligibility Criteria
Inclusion Criteria: Age between 18-80 years Cases of cholelithiasis with concomitant CDL in whom CBD clearance is achieved will be included. Exclusion Criteria: Informed consent not available Patients opting for single stage surgery Previous hepatobiliary surgery Failure to completely clear CDL on ERC Concomitant benign biliary strictures (like chronic pancreatitis, portal cavernoma cholangiopathy, post cholecystectomy, primary biliary cholangitis related) Previous cholecystectomy patients Associated malignancy Coagulopathy(INR>1.5, platlets<1lac) Severe cholangitis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Group A - Patients will undergo stent removal and cholangiogram at 3 months of follow up
Group B - Patients will undergo endoscopic ultrasound (EUS) at 3 months of follow up.
In group A, patients will undergo stent removal and cholangiogram at 3 months of follow up. If we detect recurrent stone/s on cholangiogram, clearance will be done accordingly. If the patient is dated for cholecystectomy beyond 3 months then stent exchange will be done and patient will be followed up till they undergo cholecystectomy. During this waiting period in the later group, patients will undergo monthly follow up for development of any new onset symptoms that are suggestive of biliary pain, pancreatitis, cholangitis and cholecystitis.
In group B, patients will undergo endoscopic ultrasound (EUS) at 3 months of follow up. If we detect recurrent stone/s in EUS then ERC and clearance will be done accordingly. Those who are dated for cholecystectomy beyond 3 months will undergo monthly follow up clinically (biliary pain, pancreatitis, cholangitis and cholecystitis) till they undergo cholecystectomy. Those patient in group B who are unwilling for EUS will be requested to get an magnetic resonance cholangiopancreatography (MRCP) while those unwilling for both EUS/MRCP will be followed up with ultrasound abdomen and liver function test (LFT).