SphinX trial
Research type
Research Study
Full title
Endoscopic sphincterotomy before fully covered self-expandable metal stent placement for malignant distal biliary obstruction to prevent pancreatitis: a randomised controlled trial- The SphinX-trial
IRAS ID
172725
Contact name
Noor Bekkali
Contact email
Sponsor organisation
University College Hospital London
Clinicaltrials.gov Identifier
5270, NTR; 16/SC/0383, REC-South Central-Oxford B
Duration of Study in the UK
4 years, 0 months, 0 days
Research 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 (ES) 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. The aim of this study is therefore to investigate the role of endoscopic sphincterotomy prior to biliary fully covered SEMS (FCSEMS) placement in the prevention of post-ERCP pancreatitis.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0383
Date of REC Opinion
23 Sep 2016
REC opinion
Further Information Favourable Opinion