Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
Conditions
Interventions
Intervention1: EUS guided Choledochoduodenostomy: In this procedure, a partially covered metal stent will be placed through the duodenums first part to dilate the common bile duct. After 4 weeks patie
Sponsors
Dr Praveer Rai
Eligibility
Inclusion criteria
Inclusion criteria: 1. Radiological diagnosis (with or without pathological confirmation) of resectable malignant biliary obstruction at least 2 cm distal to the hilum 2. Elevated liver tests with serum bilirubin > 3 ULN and dilated extra-hepatic bile duct measuring at least 1.2 cm on axial imaging or US. 3. ECOG less than or 2 4. Provision of informed consent 5. No serious or uncontrolled coexisting medical illness
Exclusion criteria
Exclusion criteria: 1. Uncorrectable coagulopathy and/or thrombocytopenia (INR >1.5, PLT 2. Age 3. Liver metastasis 4. Liver cirrhosis with portal hypertension or ascites 5. Prior biliary sphincterotomy or stent placement 6. Gastric outlet obstruction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Successful surgery without reintervention rate between two groupsTimepoint: 4 Weeks after biliary drainage | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Technical success: defined as the successful placement of a stent 2. Clinical success: defined as a 50% decrease in bilirubin 2 weeks post stent insertion or less than 25% of pre-procedure bilirubin level within 4 weeks post stent insertion 3. Rate of reintervention 4. Stent Patency: defined as the mean time to stent obstruction or migration 5. Early adverse events (within 14 days of index procedure) as defined include postprocedural bleeding, intestinal perforation, and cholangitis 6. Delayed adverse events (greater than 14 days of index procedure until last follow-up or death) 7. Endoscopic procedure time: defined as from insertion of the endoscope to endoscope withdrawal 8. Operation times 9. Intraoperative blood loss 10. Number of days of hospitalisation during surgery 11. Postoperative adverse events are defined according to the Clavien-Dindo classification Timepoint: Clinical success at 2 weeek, Early adverse events with in 2 week after index procedure, Late adverse events after 2 week of procedure or till last follow up | — |
Countries
India
Contacts
Public ContactDr Praveer Rai
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
Outcome results
None listed