Endobiliary radiofrequency ablation as treatment for occluded extra-hepatic biliary metal stents: a prospective multicenter feasibility study.
- Conditions
- pancreascarcinoommalignant extra-hepatic biliary obstruction1001981510019818
- Registration Number
- NL-OMON38754
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
• 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
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Biliary patency, defined as the time period between study intervention and<br /><br>biliary re-obstruction.</p><br>
- Secondary Outcome Measures
Name Time Method <p>technical success; clinical success; complications; hospitalisation; median<br /><br>survival</p><br>