Tae Jun Song1, Sang Soo Lee1, Jong Ho Moon2, Hyun Jong Choi2, Chang Min Cho3, Kwang Hyuck Lee4, Se Woo Park5, Seong-Hun Kim6, Seung Ok Lee6, Yun Nah Lee2, Jong Kyun Lee4. 1. Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 2. Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon, Republic of Korea. 3. Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, Daegu, Republic of Korea. 4. Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 5. Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Dongtan, Republic of Korea. 6. Department of Internal Medicine, Chonbuk National University Hospital, Jeonju, Republic of Korea.
Abstract
BACKGROUND AND AIMS: Recently, a newly designed lumen-apposing metal stent (LAMS) with a conventional delivery system was developed. The purpose of this study was to evaluate the effectiveness and safety of a newly designed LAMS for EUS-guided drainage to treat symptomatic pancreatic pseudocysts. METHODS: This prospective multicenter cohort study included 34 patients with symptomatic pancreatic pseudocysts from 2016 to 2017. The patients underwent EUS-guided drainage with the newly designed LAMS (Niti-S SPAXUS; Taewoong Medical Co, Ltd, Ilsan, South Korea). Effectiveness outcome measurements included technical success rate, clinical success rate, successful stent removal rate, and procedural time. Safety outcome measurements included procedure and/or stent-related adverse events (AEs) and overall AEs. Patients were prospectively followed, and consecutive data were collected at discharge, at stent removal, and 20 days after stent removal. RESULTS: Thirty-four patients (mean age 51.7 ± 13.3 years, 26 men) were enrolled. The mean pseudocyst size was 9.23 ± 3.54 cm. The technical success rate was 97.1% (33/34). The clinical success rate was 94.1% (32/34). All stents were successfully removed. The mean procedural time from needle puncture to stent deployment was 10.3 ± 5.7 minutes. Four patients (11.8%) experienced procedure and/or stent-related AEs, including stent maldeployment (n = 1) and pseudocyst infection (n = 3). All patients completely recovered from the AEs. Bleeding caused by the stent or buried LAMS syndrome was not observed. No unplanned endoscopic procedures were required. CONCLUSIONS: This study showed that EUS-guided drainage using the newly designed LAMS is technically feasible and effective for the treatment of symptomatic pancreatic pseudocysts. (Clinical trial registration number: NCT02730663.).
BACKGROUND AND AIMS: Recently, a newly designed lumen-apposing metal stent (LAMS) with a conventional delivery system was developed. The purpose of this study was to evaluate the effectiveness and safety of a newly designed LAMS for EUS-guided drainage to treat symptomatic pancreatic pseudocysts. METHODS: This prospective multicenter cohort study included 34 patients with symptomatic pancreatic pseudocysts from 2016 to 2017. The patients underwent EUS-guided drainage with the newly designed LAMS (Niti-S SPAXUS; Taewoong Medical Co, Ltd, Ilsan, South Korea). Effectiveness outcome measurements included technical success rate, clinical success rate, successful stent removal rate, and procedural time. Safety outcome measurements included procedure and/or stent-related adverse events (AEs) and overall AEs. Patients were prospectively followed, and consecutive data were collected at discharge, at stent removal, and 20 days after stent removal. RESULTS: Thirty-four patients (mean age 51.7 ± 13.3 years, 26 men) were enrolled. The mean pseudocyst size was 9.23 ± 3.54 cm. The technical success rate was 97.1% (33/34). The clinical success rate was 94.1% (32/34). All stents were successfully removed. The mean procedural time from needle puncture to stent deployment was 10.3 ± 5.7 minutes. Four patients (11.8%) experienced procedure and/or stent-related AEs, including stent maldeployment (n = 1) and pseudocyst infection (n = 3). All patients completely recovered from the AEs. Bleeding caused by the stent or buried LAMS syndrome was not observed. No unplanned endoscopic procedures were required. CONCLUSIONS: This study showed that EUS-guided drainage using the newly designed LAMS is technically feasible and effective for the treatment of symptomatic pancreatic pseudocysts. (Clinical trial registration number: NCT02730663.).