Efficacy and safety of self-expandable metal stents for biliary decompression in patients receiving neoadjuvant therapy for pancreatic cancer: A prospective study

Background: Increasing numbers of patients with resectable pancreatic cancer are receiving neoadjuvant therapy. Biliary drainage with plastic stents during this period can be associated with recurrent episodes of stent occlusion resulting in unplanned ERCPs and interruptions in therapy. Objective: To evaluate the efficacy and safety of self-expandable metal stents (SEMSs) during the neoadjuvant period for resectable pancreatic cancer. Design: Patients with proven pancreatic adenocarcinoma with biliary obstruction underwent placement of SEMSs, and data on stent patency and complication rates were collected prospectively. Setting: Tertiary-care referral center. Patients: This study involved 55 patients with resectable and borderline resectable pancreatic duct adenocarcinoma who were recruited between March 2009 and December 2010. Intervention: SEMSs were placed for biliary decompression. The shortest length of stent required to bridge the stricture was used so as to leave enough of the normal bile duct above the stent available for subsequent surgical anastomosis. Endoscopic reintervention was performed in those with stent malfunction. Stents were not removed before surgery. Main Outcome Measurements: Stent patency rate during the neoadjuvant period, stent malfunction rate, and complication rates. Information on stent-related difficulties, if any, during surgery. Results: Fifty-five patients were recruited (29 men, 26 women; age, mean [± SD] 65.9 ± 11 years; resectable 23, borderline resectable 32). Median time for neoadjuvant therapy and restaging before surgery was 104 days (range 70-260 days). At the median time of 104 days, 88% of SEMSs remained patent. By 260 days, stent malfunction occurred in 15% of patients. These included stent occlusion in 13% and stent migration in 2%. SEMS malfunction occurred in 3 of 27 patients (11%) who ultimately underwent pancreaticoduodenectomy and in 5 of 21 patients (24%) with disease progression (P = not significant). The presence of SEMSs did not interfere with pancreaticoduodenectomy in any patients who underwent surgery. Limitations: Nonrandomized study. Conclusion: SEMSs are effective and safe in achieving durable biliary drainage in patients with pancreatic cancer receiving neoadjuvant therapy. It is not necessary to remove SEMSs before surgery if the shortest length of stent required to bridge the stricture is used.