Health Condition 1: null- Distal biliary obstruction with obstructive jaundice
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 Willing and able to comply with the study procedures and provide written informed consent to participate in the study 2 Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and ampullary cancers 3 Biliary obstructive symptoms or signs 4 Bilirubin level > 2 mg/dl 5 Patients deemed as resectable by pancreatic protocol CT or MRI 6 Surgery intent within 4 weeks
Exclusion criteria
Exclusion criteria: 1 Biliary strictures caused by confirmed benign tumors 2 Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and ampullary cancers. 3 Hilar stricture or obstruction due to any cause. 4 Neoadjuvant chemotherapy for current malignancy 5 Palliative indication due to reasons other than surgical candidate status 6 Previous biliary drainage by ERCP/PTC 7 Patients for whom endoscopic techniques are contraindicated 8 Participation in another investigational trial within 180 days 9 Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the technical & clinical success and immediate complications of preoperative biliary drainage by EUS-HGS in patients with distal malignant biliary obstructionTimepoint: 2, 4, 6, 8 weeks follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| After EUS-HGS in postoperative period (after surgery) to study 1 Length of hospital stay after surgery 2 Biliary obstruction symptoms assessment (Jaundice and prurutis) Timepoint: 4 weeks | — |
Countries
India
Contacts
Global Hospital, Mumbai