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
Source
Brief title
Condition
- Hepatobiliary neoplasms
Health condition
Malignant biliary obstruction Endoscopic biliary sphincterotomy Post-ERCP pancreatitis
Research involving
Sponsors and support
Intervention
- Other intervention
Outcome measures
Primary outcome
Incidence of post-ERCP pancreatitis
Secondary outcome
- 30-days ERCP-related morbidity
- 30 days stent-related morbidity
- 30 days mortality
- Technical success of stent placement
Background summary
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.
Study objective
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.
Study design
Primary and secondary endpoints will be evaluated at day 7 and day 30 after ERCP.
Intervention
Department of Gastroenterology & Hepatology, C2-310
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31(0)205668708
e.e.halsemavan@amc.nl
Department of Gastroenterology & Hepatology, C2-310
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31(0)205668708
e.e.halsemavan@amc.nl
Age
Inclusion criteria
- 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
Exclusion criteria
- 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
Design
Recruitment
IPD sharing statement
Dr. Nassaulaan 10
9401 HK Assen
059 2405871
info@stbebo.nl
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 | NL5130 |
| NTR-old | NTR5270 |
| Other | MEC AMC : 2015_176 |
| CCMO | NL54248.018.15 |
| OMON | NL-OMON55849 |