Kentaro Yamao1, Mamoru Takenaka2, Takeshi Ogura3, Hiroaki Hashimoto4, Hisakazu Matsumoto5, Masashi Yamamoto6, Tsukasa Ikeura7, Akira Kurita8, Zhao Liang Li9, Hideyuki Shiomi10, Yasutaka Chiba11, Masatoshi Kudo2, Tsuyoshi Sanuki12. 1. Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, 589-8511, Japan. yamaken_volvo@yahoo.co.jp. 2. Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, 589-8511, Japan. 3. The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Osaka, 569-8686, Japan. 4. Department of Gastroenterology, Bell Land General Hospital, Sakai, Osaka, 599-8247, Japan. 5. Department of Gastroenterology, Japanese Red Cross Wakayama Medical Center, Wakayama, 640-8558, Japan. 6. Department of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka, Osaka, 560-8565, Japan. 7. The Third Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, 573-1191, Japan. 8. Digestive Disease Center, Kitano Hospital, Osaka, 530-8480, Japan. 9. Department of Gastroenterology, Takarazuka City Hospital, Takarazuka, Osaka, 665-0827, Japan. 10. Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Hyogo, 650-0017, Japan. 11. Clinical Research Center, Kindai University Hospital, Osaka-Sayama, Osaka, 589-8511, Japan. 12. Department of Gastroenterology, Kita-Harima Medical Center, Ono, Hyogo, 675-1392, Japan.
Abstract
BACKGROUND: Self-expandable metal stents (SEMSs) are widely used in patients with distal malignant biliary obstruction. A SEMS that can avoid occlusion as much as possible is desirable. AIMS: The aim of this multicenter single-arm prospective study was to assess the clinical effectiveness and safety of a novel fully covered braided SEMS. METHODS: We enrolled consecutive patients with distal malignant biliary obstruction between February 2016 and November 2017 at ten tertiary-care medical centers. RESULTS: We included 79 patients with a median age of 76 years; 47 (59.5%) patients were men. The technical and clinical success rate was 98.7% and 93.6%, respectively. Recurrent biliary obstruction occurred in 14 patients (17.9%); stent ingrowth, overgrowth, migration, and other occurred in five (6.4%), four (5.1%), four (5.1%), and one (1.3%) patients, respectively. All reinterventions in patients with recurrent biliary obstruction were successful via the transpapillary approach. Adverse events occurred in 15 patients (19.2%); cholangitis, pancreatitis, and others occurred in ten (12.8%), three (3.8%), and two (2.6%) patients, respectively. The stent patency probability at 6 months was 48.5%. Median time to stent patency was 171 days, median time to recurrent biliary obstruction was 536 days, and median survival time was 195 days. CONCLUSIONS: We confirmed the utility and safety of a novel fully covered braided SEMS with low axial force and high radial force in patients with malignance biliary obstruction. This novel SEMS is recommended in patients with distal malignant biliary obstruction.
BACKGROUND: Self-expandable metal stents (SEMSs) are widely used in patients with distal malignant biliary obstruction. A SEMS that can avoid occlusion as much as possible is desirable. AIMS: The aim of this multicenter single-arm prospective study was to assess the clinical effectiveness and safety of a novel fully covered braided SEMS. METHODS: We enrolled consecutive patients with distal malignant biliary obstruction between February 2016 and November 2017 at ten tertiary-care medical centers. RESULTS: We included 79 patients with a median age of 76 years; 47 (59.5%) patients were men. The technical and clinical success rate was 98.7% and 93.6%, respectively. Recurrent biliary obstruction occurred in 14 patients (17.9%); stent ingrowth, overgrowth, migration, and other occurred in five (6.4%), four (5.1%), four (5.1%), and one (1.3%) patients, respectively. All reinterventions in patients with recurrent biliary obstruction were successful via the transpapillary approach. Adverse events occurred in 15 patients (19.2%); cholangitis, pancreatitis, and others occurred in ten (12.8%), three (3.8%), and two (2.6%) patients, respectively. The stent patency probability at 6 months was 48.5%. Median time to stent patency was 171 days, median time to recurrent biliary obstruction was 536 days, and median survival time was 195 days. CONCLUSIONS: We confirmed the utility and safety of a novel fully covered braided SEMS with low axial force and high radial force in patients with malignance biliary obstruction. This novel SEMS is recommended in patients with distal malignant biliary obstruction.
Entities:
Keywords:
Bile duct obstruction; Biliary surgical procedure; Malignancy; Obstructive jaundice; Recurrence; Self-expandable metal stents
Authors: Muhammad Ali Khan; Ali Akbar; Todd H Baron; Sobia Khan; Mehmat Kocak; Yaseen Alastal; Tariq Hammad; Wade M Lee; Aijaz Sofi; Everson L A Artifon; Ali Nawras; Mohammad Kashif Ismail Journal: Dig Dis Sci Date: 2015-10-30 Impact factor: 3.199