Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
Conditions
Interventions
Intervention1: Endoscopic ultrasound guided choledochoduodenostomy (EUS-CDS): After informed consent, patients will be taken up for EUS-guided choledochoduodenostomy.
Pre-operative biliary drainage w
Sponsors
National Cancer Grid Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: distal malignant biliary obstruction resectable or borderline resectable malignancy naive case with no prior endoscopic/radiological/surgical biliary obstruction Both, EUS-CDS and ERCP can be performed (able to reach papilla) Indications for pre-operative biliary drainage (any one indication to be present at the time of randomization): hyperbilirubinemia; prior neoadjuvant therapy; intractable pruritis; cholangitis; multidisciplinary team decision for optimization of patient before surgery informed consent by patient or legally acceptable representative or impartial witness as applicable
Exclusion criteria
Exclusion criteria: hilar malignant biliary obstruction benign causes of biliary obstruction altered GI anatomy unstable clinical conditions pregnancy prior sphincterotomy or biliary stent placement uncorrectable coagulopathy or thrombocytopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite outcome of need for biliary re-intervention and/or post-endoscopic adverse eventsTimepoint: At 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Adverse event rates post-curative surgical resection b) Technical success of the index endoscopic drainage procedure c) Technical success of surgical intervention d) Duration of hospital stay e) R0 resection rates f) Re-intervention for post-operative complications g) Mortality secondary to the index endoscopic procedureTimepoint: At 6 months | — |
Countries
India
Contacts
Public ContactJayanta Samanta
PGIMER, Chandigarh
Outcome results
None listed