To investigate the role of endoscopic sphincterotomy prior to biliary fully covered SEMS (FCSEMS) placement in the prevention of post-ERCP pancreatitis.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of post-ERCP pancreatitis.
Secondary outcome
- 30-day morbidity related to ERCP (with or without sphincterotomy)
- Technical success of stent placement
- Stent-related 30-day morbidity
- 30-day mortality
Background summary
Self-expandable metal stents (SEMSs) are increasingly being used to treat
malignant common bile duct obstruction. This shift towards SEMS placement (and
away from plastic stent placement) is accompanied by a change in the
complication profile of biliary stent placement, with a sharp decrease in late
occlusion and cholangitis, but a slight increase in the incidence of post-ERCP
pancreatitis. It is hypothesised that endoscopic sphincterotomy before biliary
SEMS 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. Data on whether or not to perform ES are conflicting. As
a result, the European guideline leaves pre-stenting biliary sphincterotomy to
the preference of the endoscopist.
Study objective
To investigate the role of endoscopic sphincterotomy prior to biliary fully
covered SEMS (FCSEMS) placement in the prevention of post-ERCP pancreatitis.
Study design
A multicentre, open, randomised controlled trial.
Intervention
Patients will be randomised to FCSEMS placement with or without prior
endoscopic biliary sphincterotomy.
Study burden and risks
All patients are consented for ERCP, and for the study, and informed about the
complications associated with an ERCP: abdominal pain, bleeding, post-ERCP
pancreatitis and perforation (consent for ERCP). The main risks of endoscopic
sphincterotomy are haemorrhage (2.0%) and perforation (0.3%). In daily
practice, whether or not the patient will be subjected to a sphincterotomy
depends on the endoscopist*s preference. Therefore, the study does not
introduce an additional risk for the participant.
The presumed benefit of an endoscopic sphincterotomy is a reduction in the
post-ERCP pancreatitis rate after biliary SEMS placement, but sphincterotomy
may be accompanied by an increased risk of bleeding and perforation. Therefore,
a change in the distribution of complications could be anticipated.
The burden for patients participating in this trial is small, with only two
short telephone calls seven and thirty days after the procedure to evaluate
possible procedure-related complications.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
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. 100 mg/day)
• Known clotting disorder
• Patients unable to provide written consent for the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54248.018.15 |
| OMON | NL-OMON21209 |