Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
Conditions
Interventions
Intervention1: Endoscopic
retrograde cholangiopancreatography (ERCP): ERCP will be done in three groups with described intervention below.
a) Fully covered Biliary SEMS
b) Multiple plastic stents
c) C
Sponsors
BSBY
Eligibility
Inclusion criteria
Inclusion criteria: 1)Age group - greater than or equal to 18 years 2)Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice {Total bilirubin greater than or equal to 2.5mg/dl} for at least 1 month or persistent cholestasis associated with at least 3 times normal alkaline phosphatase levels) documented at time of enrolment for naive stricture or at the time of prior plastic stent placement in strictures that had 1 prior plastic stent inserted 3)Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts. 4)Benign etiologies like chronic pancreatitis, post cholecystectomy and idiopathic.
Exclusion criteria
Exclusion criteria: 1)Malignant bile duct stricture 2)A prior biliary metal stent or more than 1 plastic stent for 6 months 3)Stricture within 2 cm of common bile duct bifurcation 4)Portal cavernous cholangiopathy, 5)Known bile duct fistula or leak, 6)Symptomatic duodenal stenosis with gastric stasis, 7)Contraindication to endoscopic techniques or devices, 8)Refusal to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile and complication rates in all the 3 groups throughout the study period.Timepoint: At end of 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare biliary stricture resolution 2 years after initial stent(s) defined as the absence of re- stenting after the stenting period and 2 years serum alkaline phosphatase level not exceeding twice the level at the end of the stenting period.Timepoint: at end of 2 years;To compare the technical success and treatment failure of stent placementTimepoint: At end of 2 years;Number of endoscopic retrograde cholangiopancreatography (ERCP) procedures during 2 years after initial stent placementTimepoint: At end of 2 years;Total number of stents placed during the study and duration of stent placement procedureTimepoint: | — |
Countries
India
Contacts
Public ContactDr Ashok Jhajharia
Sawai Man Singh Medical college
Outcome results
None listed