Bing Hu 1 , Tian-tian Wang 1 , Jun Wu 1 , Zhi-mei Shi 1 , Dao-jian Gao 1 , Ya-min Pan 1 Show Affiliations »
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BACKGROUND AND STUDY AIMS: There are limited data on the role of antireflux biliary stents . This single-center randomized trial compared the endoscopic use of partly covered antireflux metal stents (pcARMS) with that of standard uncovered self-expandable metal stents (ucSEMS ) for the palliation of nonhilar malignant biliary obstruction . PATIENTS AND METHODS: Between August 2007 and February 2012, patients with nonhilar malignant biliary obstruction were randomly assigned to treatment with either pcARMS or ucSEMS . Subsequent follow-up was conducted in clinic or by phone. The primary outcome was onset of cholangitis within 12 months of stenting . Secondary outcomes included other morbidities, stent dysfunctions, and survival . RESULTS: Altogether 112 patients were included, 56 in each group . The stents were successfully deployed in all patients. Satisfactory jaundice control was achieved in 49 cases in the pcARMS group, compared with 47 in the ucSEMS group (P = 0.135). Fewer patients experienced cholangitis in the pcARMS group than in the ucSEMS group (10 vs. 21 patients; P = 0.035), and the frequency of episodes was less (P = 0.022). Respectively, 17 and 29 stent dysfunctions before death were observed in the pcARMS and ucSEMS groups (P = 0.051) and the median stent patency was 13.0 (standard deviation [SD] 3.4) and 10.0 (1.2) months, respectively (P = 0.044). At final follow-up, in January 2013, 50 /52 and 52 /55 patients had died and no difference in median survival was seen between the two groups (8.0 vs. 9.0 months, P = 0.56). CONCLUSIONS: Stenting with pcARMS compared with standard ucSEMS reduces risk of ascending cholangitis and has longer stent patency , but does not increase patient survival . Chictr.org. number, ChiCTR-TRC-11001800. © Georg Thieme Verlag KG Stuttgart · New York.
RCT Entities: Population
Interventions
Outcomes
BACKGROUND AND STUDY AIMS: There are limited data on the role of antireflux biliary stents. This single-center randomized trial compared the endoscopic use of partly covered antireflux metal stents (pcARMS) with that of standard uncovered self-expandable metal stents (ucSEMS) for the palliation of nonhilar malignant biliary obstruction . PATIENTS AND METHODS: Between August 2007 and February 2012, patients with nonhilar malignant biliary obstruction were randomly assigned to treatment with either pcARMS or ucSEMS. Subsequent follow-up was conducted in clinic or by phone. The primary outcome was onset of cholangitis within 12 months of stenting. Secondary outcomes included other morbidities, stent dysfunctions, and survival. RESULTS: Altogether 112 patients were included, 56 in each group. The stents were successfully deployed in all patients . Satisfactory jaundice control was achieved in 49 cases in the pcARMS group, compared with 47 in the ucSEMS group (P = 0.135). Fewer patients experienced cholangitis in the pcARMS group than in the ucSEMS group (10 vs. 21 patients ; P = 0.035), and the frequency of episodes was less (P = 0.022). Respectively, 17 and 29 stent dysfunctions before death were observed in the pcARMS and ucSEMS groups (P = 0.051) and the median stent patency was 13.0 (standard deviation [SD] 3.4) and 10.0 (1.2) months, respectively (P = 0.044). At final follow-up, in January 2013, 50 /52 and 52 /55 patients had died and no difference in median survival was seen between the two groups (8.0 vs. 9.0 months, P = 0.56). CONCLUSIONS: Stenting with pcARMS compared with standard ucSEMS reduces risk of ascending cholangitis and has longer stent patency, but does not increase patient survival. Chictr.org. number, ChiCTR-TRC-11001800. © Georg Thieme Verlag KG Stuttgart · New York.
Entities: Chemical
Disease
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Year: 2014
PMID： 24477367 DOI： 10.1055/s-0034-1364872
Source DB: PubMed Journal: Endoscopy ISSN： 0013-726X Impact factor: 10.093