A Prospective Multicenter Study of Partially Covered Metal Stents in Patients Receiving Neoadjuvant Chemotherapy for Resectable and Borderline Resectable Pancreatic Cancer: BTS-NAC Study
Kei Saito,
Yousuke Nakai,
Hiroyuki Isayama,
Ryuichi Yamamoto,
Kazumichi Kawakubo,
Yuzo Kodama,
Akio Katanuma,
Atsushi Kanno,
Masahiro Itonaga,
Kazuhiko Koike
Affiliations
Kei Saito
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Japan
Yousuke Nakai
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Japan
Hiroyuki Isayama
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Japan
Ryuichi Yamamoto
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan
Kazumichi Kawakubo
Department of Gastroenterology and Hepatology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan
Yuzo Kodama
Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan
Akio Katanuma
Department of Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Japan
Atsushi Kanno
Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan
Masahiro Itonaga
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
Kazuhiko Koike
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Japan
Background/Aims: The aim of this study was to evaluate the safety and efficacy of partially covered self-expandable metallic stents (PCSEMS) in patients undergoing neoadjuvant chemo(radio) therapy (NAC) for pancreatic cancer (PC). Methods: This was a prospective multicenter study to evaluate the safety and efficacy of PCSEMS in patients receiving NAC for resectable and borderline resectable PC. The primary endpoint was the rate of recurrent biliary obstruction (RBO). Results: Twenty-six patients with PC (three with resectable PC and 23 with borderline resectable PC) who underwent NAC at seven Japanese centers were included in the analysis. Both the technical and functional success rates of PCSEMS placement were 100%. Early stent-related complications were observed in three patients (11.5%): mild pancreatitis (n=2) and mild liver abscess (n=1). The median time to surgery or palliation was 4.0 months. Surgical resection was eventually performed in 73.1% of patients, and stent removal during surgery was successful in all patients. RBO was observed in nine patients (34.6%): seven with stent occlusion, one with kinking and one with migration. The RBO rates in resected cases and nonresected cases were 36.8% and 28.6%, respectively. Conclusions: Biliary drainage by PCSEMS was safe and feasible in patients undergoing NAC for resectable and borderline resectable PC.
