Covered self‐expandable metal stents versus plastic stents for preoperative biliary drainage in patient receiving neo‐adjuvant chemotherapy for borderline resectable pancreatic cancer: Prospective randomized study

• DOI: 10.1111/den.13926
• Publication Date: 2021-01-10T16:56:38Z
• Authors: Takashi Tamura; Masahiro Itonaga; Reiko Ashida; Yasunobu Yamashita; Keiichi Hatamaru; Yuki Kawaji; Tomoya Emori; Yuji Kitahata; Motoki Miyazawa; Seiko Hirono; Ken‐ichi Okada; Manabu Kawai; Toshio Shimokawa; Hiroki Yamaue; Masayuki Kitano
• Keywords: Cholangiopancreatography, Endoscopic Retrograde; Cholestasis; Self Expandable Metallic Stents; Neoadjuvant Therapy; 3. Good health; Pancreatic Neoplasms; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Drainage; Humans; Stents; Prospective Studies; Plastics

ObjectivesThis single‐center comparative randomized superiority study compared biliary stenting using fully covered self‐expandable metal stents (FCSEMS) and biliary stenting using plastic stents (PS) in preoperative biliary drainage of patients with borderline resectable pancreatic cancer (BRPC) who are planned to undergo a single regimen of neo‐adjuvant chemotherapy (NAC).MethodsTwenty‐two patients with BRPC who required preoperative biliary drainage before NAC (Gemcitabine plus Nab‐paclitaxel) were randomly assigned 1:1 to the FCSEMS or PS group. The primary endpoint was the rate of stent dysfunction until surgery or tumor progression. Secondary endpoints were stent patency, number of re‐interventions, adverse events of endoscopic retrograde biliary drainage (EBD), operation time, volume of intraoperative bleeding, postoperative hospitalization, postoperative adverse events and medical costs.ResultsEleven patients in each of the groups reached the primary endpoint. The FCSEMS group showed a significantly lower rate of stent dysfunction (18.2% vs. 72.8%, P = 0.015), longer stent patency (P = 0.02), and lower number of re‐interventions for stent dysfunction (0.27 ± 0.65 vs. 1.27 ± 1.1, P = 0.001) than the PS group. The adverse events of EBD, operation time, volume of intraoperative bleeding, postoperative hospitalization, postoperative adverse events and medical costs did not significantly differ between the two groups.ConclusionsIn patients with BRPC for preoperative biliary drainage, stent dysfunction occurred less frequently with FCSEMSs than with PSs. In addition, FCSEMS and PS provided similar preoperative management of BRPC in terms of the safety of surgery and medical costs. (UMIN ID000030473).