pancreascarcinoom malignant extra-hepatic biliary obstruction
Conditions
Interventions
Application of endobiliary RFA with the HabibTM EndoHPB device at the site of
biliary obstruction during 2 minutes at a power setting of 7 Watt.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients with unresectable malignant common bile duct obstruction caused by pancreatic head carcinoma or distal cholangiocarcinoma who have been treated previously with a biliary uncovered SEMS • Recurrent biliary obstruction caused by SEMS occlusion due to tissue ingrowth, requiring treatment • A clinical diagnosis of obstructive jaundice in combination with a bilirubin level of >40 µmol/L and
Exclusion criteria
Exclusion criteria: • Patients with a (malignant) biliary obstruction due to other causes than pancreatic head cancer or cholangiocarcinoma • Evidence of new additional more proximally located biliary strictures • Clinical suspicion of cholangitis, defined as biliary obstruction in combination with fever (temperature >= 38,5°C) • Presence of a plastic stent in the common bile duct. • Patients who are unable to undergo ERCP due to their medical condition • Patients suffering form concurrent gastric outlet obstruction • Patients with a cardiac pacemaker • Patients with a WHO performance score of 4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biliary patency, defined as the time period between study intervention and biliary re-obstruction. | — |
Secondary
| Measure | Time frame |
|---|---|
| technical success; clinical success; complications; hospitalisation; median survival | — |
Countries
Netherlands
Outcome results
None listed