We hypothesise that endoscopic sphincterotomy before biliary fully covered self-expandable metal stent (FCSEMS) placement may reduce the occurrence of post-ERCP pancreatitis by widening the orifice of the major duodenal papilla and reducing…
ID
Bron
Verkorte titel
Aandoening
- Hepatobilaire neoplasmata
Aandoening
Malignant biliary obstruction Endoscopic biliary sphincterotomy Post-ERCP pancreatitis
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
- Overige
Uitkomstmaten
Primaire uitkomstmaten
Incidence of post-ERCP pancreatitis
Achtergrond van het onderzoek
In this multicenter, open, randomised controlled trial we investigate the role of endoscopic sphincterotomy prior to biliary FCSEMS placement in the prevention of post-ERCP pancreatitis. Patients with extrahepatic malignant biliary obstruction requiring FCSEMS placement will be randomised between yes/no biliary sphincterotomy prior the FCSEMS placement. The primary endpoint is the incidence of post-ERCP pancreatitis.
Doel van het onderzoek
We hypothesise that endoscopic sphincterotomy before biliary fully covered self-expandable metal stent (FCSEMS) placement may reduce the occurrence of post-ERCP pancreatitis by widening the orifice of the major duodenal papilla and reducing compression of the pancreatic sphincter.
Onderzoeksopzet
Primary and secondary endpoints will be evaluated at day 7 and day 30 after ERCP.
Onderzoeksproduct en/of interventie
Algemeen / deelnemers
Department of Gastroenterology & Hepatology, C2-310
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31(0)205668708
e.e.halsemavan@amc.nl
Wetenschappers
Department of Gastroenterology & Hepatology, C2-310
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31(0)205668708
e.e.halsemavan@amc.nl
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Indication for fully covered self-expandable metal stent placement
- (Suspected) malignant biliary outflow obstruction
- Biliary stenosis located ≥ 2 cm distal from the hilum
- Age ≥ 18 years
- Written informed consent for the procedure and study participation
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Hilar biliary obstruction, defined as stenosis located within 2 cm of the hilum
- Biliary SEMS or more than 1 plastic endoprothesis in situ
- Precut sphincterotomy or standard sphincterotomy
- Prophylactic pancreatic duct stent, even when the PD-stent is subsequently removed
- Continued use of anticoagulants or antiplatelet drugs with the exception of low-dose aspirin (max. 100mg/day)
- Known clotting disorder
- Patients unable to provide written consent for the study
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Dr. Nassaulaan 10
9401 HK Assen
059 2405871
info@stbebo.nl
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| Register | ID |
|---|---|
| NTR-new | NL5130 |
| NTR-old | NTR5270 |
| Ander register | MEC AMC : 2015_176 |
| CCMO | NL54248.018.15 |
| OMON | NL-OMON55849 |