Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial

Abstract

Background and Aims Preoperative biliary drainage with self-expanding metal stents (SEMSs) brings liver function within acceptable range in preparation for neoadjuvant therapy (NATx) and provides relief of obstructive symptoms in patients with pancreatic cancer. We compared fully covered SEMSs (FCSEMSs) and uncovered SEMSs (UCSEMSs) for sustained biliary drainage before and during NATx. Methods Patients with pancreatic cancer and planned NATx needing treatment of jaundice and/or cholestasis before pancreaticoduodenectomy were randomized to FCSEMS versus UCSEMS. Primary endpoint was sustained biliary drainage, defined as absence of reinterventions for biliary obstructive symptoms, and was assessed from SEMS placement until curative intent surgery (CIS) or 1 year. Results The intent-to-treat population had 119 patients (59 FCSEMS, 60 UCSEMS). Sustained biliary drainage was equally successful with FCSEMS and UCSEMS (72.2% vs 72.9%, noninferiority P=0.01). Reasons for FCSEMS and UCSEMS failure differed significantly between groups and included tumor ingrowth in 0 versus 16.7%, P<0.01, and stent migration in 6.8% vs. 0, P=0.03, respectively. Serious adverse event rates related to stent placement were insignificantly different in both groups (23.7% (14/59) vs 20.0% (12/60), P=0.66), as were acute cholecystitis rates when gallbladder in situ (9.3% (4/43) vs 4.8% (2/42), P=0.68) for FCSEMSs and UCSEMSs, respectively. In our study, independent of stent type, predictors of reinterventions were 4 cm stent length and presence of gallbladder. Conclusion FCSEMSs and UCSEMSs provide similar preoperative management of biliary obstruction in pancreatic cancer patients receiving NATx, but mechanisms of stent dysfunction depend on stent type, stent length, and presence of the gallbladder.