PMID- 36084714 OWN - NLM STAT- MEDLINE DCOM- 20221219 LR - 20230522 IS - 1097-6779 (Electronic) IS - 0016-5107 (Linking) VI - 97 IP - 1 DP - 2023 Jan TI - Covered versus uncovered double bare self-expandable metal stent for palliation of unresectable extrahepatic malignant biliary obstruction: a randomized controlled multicenter trial. PG - 132-142.e2 LID - S0016-5107(22)01950-2 [pii] LID - 10.1016/j.gie.2022.08.041 [doi] AB - BACKGROUND AND AIMS: In a recent randomized controlled trial, a double bare metal stent (DBS) showed better stent patency than single-layer metal stents. However, clear evidence comparing the efficacy of uncovered (UCDBS) and partially covered (PCDBS) DBSs for distal malignant biliary obstruction (MBO) is lacking. Therefore, we compared the clinical outcomes including stent patency of UCDBSs versus PCDBSs. METHODS: A multicenter, randomized study was performed in patients with distal MBO. The primary endpoint was stent patency. Secondary endpoints were the proportion of patients with patent stents at 6 months, risk factors for stent dysfunction, overall survival, technical and clinical success rates of stent placement, and other adverse events (AEs). RESULTS: Among 258 included patients, 130 were randomly assigned to the PCDBS group and 128 to the UCDBS group. The mean duration of stent patency of the PCDBS (421.2 days; 95% confidence interval [CI], 346.7-495.7) was longer than that of the UCDBS (377.4 days; 95% CI, 299.7-455.0), although total stent dysfunction and stent dysfunction within 6 months were not different between groups. Multivariate analysis indicated that chemotherapy after stent placement was a significant factor for overall survival (hazard ratio, .570; 95% CI, .408-.796) and had a marginal impact on stent patency (hazard ratio, 1.569; 95% CI, .923-2.667). There were no remarkable differences in AEs, including pancreatitis, cholecystitis, and stent migration, between the 2 groups. CONCLUSIONS: The use of PCDBSs compared with UCDBSs in patients with distal MBO has unclear bene fi ts regarding stent patency and overall survival, although PCDBSs have a lower rate of tumor ingrowth. (Clinical trial registration number: NCT02937246.). CI - Copyright (c) 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved. FAU - Park, Se Woo AU - Park SW AD - Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-do, Korea. FAU - Lee, Kyong Joo AU - Lee KJ AD - Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-do, Korea. FAU - Chung, Moon Jae AU - Chung MJ AD - Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. FAU - Jo, Jung Hyun AU - Jo JH AD - Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. FAU - Lee, Hee Seung AU - Lee HS AD - Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. FAU - Park, Jeong Youp AU - Park JY AD - Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. FAU - Park, Seung Woo AU - Park SW AD - Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. FAU - Song, Si Young AU - Song SY AD - Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. FAU - Kang, Huapyong AU - Kang H AD - Department of Internal Medicine, Gachon University College of Medicine, Gil Medical Center, Incheon, Korea. FAU - Kim, Eui Joo AU - Kim EJ AD - Department of Internal Medicine, Gachon University College of Medicine, Gil Medical Center, Incheon, Korea. FAU - Kim, Yeon Suk AU - Kim YS AD - Department of Internal Medicine, Gachon University College of Medicine, Gil Medical Center, Incheon, Korea. FAU - Cho, Jae Hee AU - Cho JH AD - Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. FAU - Bang, Seungmin AU - Bang S AD - Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. LA - eng SI - ClinicalTrials.gov/NCT02937246 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20220907 PL - United States TA - Gastrointest Endosc JT - Gastrointestinal endoscopy JID - 0010505 SB - IM CIN - Gastrointest Endosc. 2023 Mar;97(3):603. PMID: 36801021 MH - Humans MH - Palliative Care MH - Treatment Outcome MH - *Cholestasis, Extrahepatic/etiology MH - Stents/adverse effects MH - *Neoplasms/complications MH - *Cholestasis/etiology/surgery EDAT- 2022/09/10 06:00 MHDA- 2022/12/20 06:00 CRDT- 2022/09/09 19:23 PHST- 2022/01/28 00:00 [received] PHST- 2022/08/09 00:00 [revised] PHST- 2022/08/30 00:00 [accepted] PHST- 2022/09/10 06:00 [pubmed] PHST- 2022/12/20 06:00 [medline] PHST- 2022/09/09 19:23 [entrez] AID - S0016-5107(22)01950-2 [pii] AID - 10.1016/j.gie.2022.08.041 [doi] PST - ppublish SO - Gastrointest Endosc. 2023 Jan;97(1):132-142.e2. doi: 10.1016/j.gie.2022.08.041. Epub 2022 Sep 7.