No registrations found.
ID
Source
Health condition
pancreatic carcinoma
cholangiocarcinoma
malignant biliary obstruction
biliary metal stent occlusion
pancreascarcinoom
cholangiocarcinoom
maligne galwegobstructie
biliaire metalen stent occlusie
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
• 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)
Background summary
N/A
Study design
Baseline
Every 2 weeks following RFA treatment by telepone for a maximum of 6 months of follow-up.
Intervention
Application 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.
Room C2-310
M.W. Berg, van den
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
M.W.vandenBerg@amc.uva.nl
Room C2-310
M.W. Berg, van den
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
M.W.vandenBerg@amc.uva.nl
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 criteria
Baseline:
• 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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3911 |
| NTR-old | NTR4081 |
| CCMO | NL43040.018.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38754 |