CLINICAL EFFICACY AND ADVERSE EVENTS OF FULLY COVERED SELF-EXPANDABLE METAL STENTS (FC-SEMS) IN PANCREATOBILIARY STENOSIS

Aims:

To analyze indications, clinical efficacy, technical incidences and complications of fully covered self-expandable metal stents (FC-SEMS) in pancreatobiliary diseases in a terciary center.

Methods:

Retrospective analysis from an ERCP database of FC-SEMS deployed in a terciary center between March 2017 to August 2011.

Results:

A total of 104 FC-SEMS were analyzed (63.5% men, 36.5% women, mean age 67 years, range 21 – 98, basal bilirrubin 6.6 +/- 8.3 mg/dl). Indications according to the aetiology were: benign 52%, malignant 48.1%, undetermined 1.9%. By frequencies: pancreatic neoplasm 24%; chronic pancreatitis 23.1%; cholangiocarcinoma 20.2%; biliary fistula 8.7%; HDA postCPRE 5.8%; post-surgical stenosis 4.8%; extrinsic 3.8%; coledocolithiasis 2.9%; acute pancreatitis 2.9%; not defined 2.9%; postERCP perforation 1%. In 88.5%, no previous plastic pancreatic stent was placed. Technical success in endoscopic deployment was 100%. 59/104 FC-SEMS were removed without technical incidences after an average time of 189 days. One case required an additional endoscopy to get the withdrawal. Global clinical success (endoscopic resolution of the stricture plus bilirrubin normalization) was achieved in 76% of cases (82% in malignant etiology Vs 69,2% in benignant). There were 32/104 (30.8%) complications (34.6% benignant etiology vs. 28% malignant, p = n.s): cholangitis 8.7%; obstruction 6.7%; migration 12.5% (proximal 4.8%; partial distal 4.8%; total distal 2.9%); acute pancreatitis 1.9%; deferred hemorrhage 1%. Seven deaths, all in oncological patients, were recorded in the first 30 days after ERCP (4 biliary sepsis, 2 broncoaspiration, 1 massive HDA).

Conclusions:

Endoscopic placement of FC-SEMS is technically simple in expert hands as well as its extraction. The risk of pancreatitis secundary to the theoretical pancreatic duct obstruction is low in our serie, even in patients without prophylactic pancreatic stent. The percentage of complications with FC-SEMSs is similar in malignant vs. benignant etiology. Clinical success depends on a correct selection of the indication.