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Endoscopisch toegediende radiofrequente ablatie als behandeling van een verstopte metalen galwegstent


- candidate number15152
- NTR NumberNTR4081
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jul-2013
- Secondary IDsNL43040.018.12 
- Public TitleEndoscopisch toegediende radiofrequente ablatie als behandeling van een verstopte metalen galwegstent
- Scientific TitleEndobiliary radiofrequency ablation as treatment for occluded extra-hepatic biliary metal stents: a prospective multicenter feasibility study.
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedPancreatic cancer, Cholangiocarcinoma, Malignant biliary obstruction, Biliary metal stent occlusion
- 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
• A clinical diagnosis of obstructive jaundice in combination with a bilirubin level of > 40 μmol/L and
• Age 18 years or older
• Informed consent
- Exclusion criteriaBaseline:
• 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
• Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study

Endoscopic:
• Failure to reach the ampulla of Vater.
• Failure to place a guidewire across the stricture.
• Re-obstruction not caused by tumour in- or overgrowth
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2013
- planned closingdate1-aug-2015
- Target number of participants20
- InterventionsApplication of endobiliary RFA via ERCP with the HabibEndoHPB probe (EMcision Limited, London, UK) at the site of biliary SEMS obstruction for a duration of 2 minutes at a power setting of 7 Watt.
- Primary outcomeSecondary 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• Technical success, defined as successful introduction of the EndoHPB catheter across the stricture and successful application of RFA at the site of stricture
• Clinical success, defined as drop in bilirubin by 50% at 2 weeks after RFA application.
• 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.
• Median procedure related hospitalization (days)
• Median survival (days)
- TimepointsBaseline
Every 2 weeks following RFA treatment by telepone for a maximum of 6 months of follow-up.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. M.W. Berg, van den
- CONTACT for SCIENTIFIC QUERIESMD. M.W. Berg, van den
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD18-jul-2013 - 2-aug-2013


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