ID
Bron
Aandoening
pancreatic carcinoma
cholangiocarcinoma
malignant biliary obstruction
biliary metal stent occlusion
pancreascarcinoom
cholangiocarcinoom
maligne galwegobstructie
biliaire metalen stent occlusie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Secondary stent patency, defined as time period (days) between RFA application and need for re-intervention for signs and symptoms of recurrent biliary obstruction.
Achtergrond van het onderzoek
N/A
Onderzoeksopzet
Baseline
Every 2 weeks following RFA treatment by telepone for a maximum of 6 months of follow-up.
Onderzoeksproduct en/of interventie
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.
Publiek
Room C2-310
M.W. Berg, van den
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
M.W.vandenBerg@amc.uva.nl
Wetenschappelijk
Room C2-310
M.W. Berg, van den
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
M.W.vandenBerg@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3911 |
NTR-old | NTR4081 |
CCMO | NL43040.018.12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON38754 |