IS PREVIOUS SPHINCTEROTOMY REQUIRED BEFORE PLACEMENT OF A BILIARY COVERED SEMS?

Aims Our aim was to assess the safety of transpapillary covered stent (CSEMS) placement without previous sphincterotomy.

Methods Prospective database with retrospective analysis including ERCPs between 2010-2020. Inclusion criteria: biliary ERCP, naive papilla and placement of CSEMS. Epidemiological data, sphincterotomy, sphincteroplasty, adverse effects (AE) according to ASGE criteria were recorded.

Results 6,720 ERCPs were performed and 321 patients included. In 83.5%, 15%, and 87% of patients, sphincterotomy, sphincteroplasty or either of the two were performed before placing the CSEMS. There were AE in 20.9%: pancreatitis (9%), perforation (2.5%), hemorrhage (6.9%) and others (2.4%), with 4 secondary deaths (1.2%) due to pancreatitis. The incidence of AE did not vary depending on whether or not a sphincterotomy was performed (20.5% vs 20.8%, p=1), with a higher risk of bleeding with sphincterotomy (8.2% vs 0%, p=0.006) and higher risk of death in patients with postERCP pancreatitis without sphincterotomy (0.4% vs 5.7%, p=0.01). Sphincteroplasty prior to CSEMS placement entailed a higher risk of AE (35% vs 18%, p=0.01), bleeding (14.6% vs 5.5%, p=0.03 ) and pancreatitis (16.7% vs 7.7%, p=0.05). With logistic regression, we verified that placement of CSEMS without prior sphincterotomy carries a lower risk of AE (OR=2.9. 95% CI=1.6-5.1) adjusted for sex, endoscopist, sphincterotomy and sphincteroplasty.

Conclusions Not to perform sphincterotomy before placing CSEMS does not increase the risk of AE, although patients with post-ERCP pancreatitis could have a worse prognosis. Sphincteroplasty prior to CSEMS placement implies a higher risk of AE.

Publication History

Article published online:
14 April 2022