Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: EUS guided stenting: Patients with inoperable malignant biliary strictures requiring biliary drainage after a failed ERCP will be randomised to EUS guided AG or EUS -HGS stenting
Contro
Sponsors
SL Raheja Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma, ampullary cancers , hilar blocks, other metastatic conditions eg LN mets, Lymphoma) • Biliary obstructive symptoms or signs • Bilirubin level/ alkaline phosphatase level above normal limits • Patients deemed as unresectable by CT / MRI / PET • Patients with failed ERCP or anticipated difficult ERCP
Exclusion criteria
Exclusion criteria: Biliary strictures caused by confirmed benign tumours • Neoadjuvant chemotherapy for current malignancy • Palliative indication due to reasons other than surgical candidate status • Previous biliary drainage by ERCP/PTC • Patients for whom endoscopic techniques are contraindicated • Participation in another investigational trial within 180 days • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We hypothesize that the stent patency via trans-luminal route is better than that via trans-papillary route. The primary aim of the study is to compare the stent patency in patients undergoing EUS guided antegrade procedure and EUS-guided HGS. Timepoint: 3, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary aim is to compare the short and long term adverse events of the two proceduresTimepoint: 3, 6 months | — |
Countries
India
Contacts
Public ContactDr Rahul Shah
SL Raheja Hospital
Outcome results
None listed