Malignant hilar biliary obstruction Malignant hilar biliary obstruction, Hilar Cholangiocarcinoma, Klatskin Tumor, Perihilar Cholangiocarcinoma, Endosonography, Endoscopic Ultrasonography, ERCP, EUS, EUS-guided biliary drainage (EUS-BD), Combination of EUS and ERCP (CERES), Percutaneous biliary drainage (PTBD)
Conditions
Interventions
Combined ERCP and EUS-BD for malignant hilar obstruction,Combined ERCP and PTBD for malignant hilar obstruction
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Combined ERCP with EUS-BD,Combined ERCP with PTBD
Sponsors
Excellence Center For GI Endoscopy, King Chulalongkorn Memorial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Patients with unresectable malignant biliary hilar obstruction 2. Patients with indication for biliary drainage 3. Patients with good liver area of more than 80% 4. Patients with ECOG score 0-2 5. Patients with expected life expectancy of more than 3 months 6. Patients age 18-90 years 7. Patients who consent to protocol
Exclusion criteria
Exclusion criteria: 1. Patients with uncorrectable coagulopathy 2. Pregnant patients 3. Patients with marked ascites which interfere with interventions 4. Patients with non-malignant biliary hilar obstruction 5. Patients who can not follow-up longer than 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent biliary obstruction 6 months Recurrence of obstructive jaundice and/or cholangitis due to stent occlusion or migration | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate Post-operation Technically success in placement of biliary stent (ERCP/EUS) or catheter (PTBD) as planned in the intended appropriate location, confrmed radiologically and/or endoscopically,Clinical success rate 4 weeks after biliary drainage Reduction in bilirubin by more than 50% of baseline at 2 weeks and/or TB less than 3 mg/dL at 4 weeks,Adverse events Post-operation until the end of follow-up period Graded as per the standard lexicon using American Society of Gastrointestinal Endoscopy criteria,Cost-effectiveness analysis Post-procedure after the end of follow-up period Cost-effectiveness analysis ,Quality of life Post-procedure after the end of follow-up period EORTC Quality of Life questionnaire | — |
Countries
Thailand
Contacts
Public ContactPradermchai Kongkam
King Chulalongkorn Memorial Hospital
Outcome results
None listed