Health Condition 1: K805- Calculus of bile duct without cholangitis or cholecystitis
Conditions
Interventions
Intervention1: Endoscopic Sphincterotomy alone: Biliary Sphincterotomy will be extended to the full length of major duodenal papilla but not exceeding the major duodenal horizontal fold avoiding cross
Sponsors
IPGMER and SSKM Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Adults greater than 18 years old with radiologically ( Ultrasound and or MRCP) confirmed Choledocholithiasis of size equal to or greater than 10mm and or more than one in number undergoing ERCP for the first time Ability to provide informed consent
Exclusion criteria
Exclusion criteria: Those with previous Biliary Sphincterotomy and or biliary stent in situ Those with recurrent choledocholithiasis after previous endoscopic choledocholithiasis clearance Patients having one or more choledocholithiasis with shortest transverse diameter greater than 15mm Patients having impacted CBD calculus with relatively narrower CBD distal to the calculus on pre ERCP MRCP Patients with Mirrizi syndrome Patients with suspected biliary ascarisis Patients having a stricture benign or malignant distal to the CBD calculus Patients with ongoing Acute pancreatitis Pancreatic head mass Ongoing hypotension including those with sepsis Patients with ongoing severe cholangitis as evidenced by the presence of one or greater organ dysfunction according to Tokyo guidelines Pregnant women Patients with significant renal illness like dialysis dependent Patients with recent or past variceal bleeding uncontrolled ascites persistent hepatic encephalopathy and severe coagulopathy INR greater than 3 Patients with acute liver failure and or acute on chronic liver failure Patients with recent Cerebrovascular accident and or Transient ischemic attack Patients on anti coagulants and or clopidogrel that cannot be stopped temporarily standard contraindications to ERCP Unwillingness or inability to consent for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate defined as proportion of patients achieving complete removal of CBD calculus confirmed by cholangiogram at the end of the procedureTimepoint: end of procedure 2 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Complication rates Incidence of post procedural pancreatitis infections bleeding perforation and other adverse events Procedure time Duration from successful deep cannulation of bile duct till procedure completion with bile duct clearanceTimepoint: 24 hours 48 hours 7 days 14 days | — |
Countries
India
Contacts
Public ContactDr Akanksha Srivastava
IPGMER and SSKM Hospital, Kolkata
Outcome results
None listed