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van CCT (UK)


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van CCT (UK)


Endoscopic cutting of the constrictor (sphincter) muscle of the bile ducts before placement of a metal tube (stent) to lower the risk of an inflammation of the pancreas


- candidate number22429
- NTR NumberNTR5270
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jul-2015
- Secondary IDs 2015_176 MEC AMC
- Public TitleEndoscopic cutting of the constrictor (sphincter) muscle of the bile ducts before placement of a metal tube (stent) to lower the risk of an inflammation of the pancreas
- Scientific TitleEndoscopic sphincterotomy before fully covered self-expandable metal stent placement for malignant extrahepatic biliary obstruction to prevent pancreatitis: a randomised controlled trial
- ACRONYMSPHINX
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedMalignant biliary obstruction, Endoscopic retrograde cholangiopancreatography (ERCP), Postoperative inflammation
- 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
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate1-mrt-2018
- Target number of participants516
- InterventionsEndoscopic biliary sphincterotomy
- Primary outcomeIncidence of post-ERCP pancreatitis
- Secondary outcome- 30-days ERCP-related morbidity
- 30 days stent-related morbidity
- 30 days mortality
- Technical success of stent placement
- TimepointsPrimary and secondary endpoints will be evaluated at day 7 and day 30 after ERCP.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD E.E. Halsema, van
- CONTACT for SCIENTIFIC QUERIESMD. Jeanin Hooft, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Cook Medical, Ireland
- Publications
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD9-jul-2015 - 18-aug-2015


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