Endoscopisch toegediende radiofrequente ablatie als behandeling van een verstopte metalen galwegstent

Recruiting

Conditions: pancreatic carcinomacholangiocarcinomamalignant biliary obstructionbiliary metal stent occlusionpancreascarcinoomcholangiocarcinoommaligne galwegobstructiebiliaire metalen stent occlusie

Registration Number: NL-OMON20857

Lead Sponsor: Academic Medical Center

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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 SEMS

• Recurrent biliary obstruction caused by SEMS occlusion due to tissue in- or overgrowth, requiring treatment

Exclusion Criteria

Baseline:

• Patients with a (malignant) biliary obstruction due to other causes than pancreatic head cancer or cholangiocarcinoma

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary stent patency, defined as time period (days) between RFA application and need for re-intervention for signs and symptoms of recurrent biliary obstruction.

Secondary Outcome Measures

Name	Time	Method
• Technical success, defined as successful introduction of the EndoHPB catheter across the stricture and successful application of RFA at the site of stricture<br /><br>• Clinical success, defined as drop in bilirubin by 50% at 2 weeks after RFA application. <br /><br>• The number of complications. Complications will be graded as either intervention-related or non-intervention-related (Serious) Adverse Events ([S]AE’s). An independent expert panel (composed out of two gastroenterologists with extensive ERCP experience) will decide upon intervention-relatedness. Examples of intervention-related (S)AE’s are: perforation, bleeding, local abscess formation, liver infarction, cholangitis, pancreatitis, aspiration pneumonia, cardiorespiratory insufficiency during endoscopy. <br /><br>• Median procedure related hospitalization (days)<br /><br>• Median survival (days)<br />