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Covered versus uncovered double bare self-expandable metal stent for palliation of unresectable extrahepatic malignant biliary obstruction: a randomized controlled multicenter trial

 Se Woo Park  ;  Kyong Joo Lee  ;  Moon Jae Chung  ;  Jung Hyun Jo  ;  Hee Seung Lee  ;  Jeong Youp Park  ;  Seung Woo Park  ;  Si Young Song  ;  Huapyong Kang  ;  Eui Joo Kim  ;  Yeon Suk Kim  ;  Jae Hee Cho  ;  Seungmin Bang 
 GASTROINTESTINAL ENDOSCOPY, Vol.97(1) : 132-142.e2, 2023-01 
Journal Title
Issue Date
Cholestasis* / etiology ; Cholestasis* / surgery ; Cholestasis, Extrahepatic* / etiology ; Humans ; Neoplasms* / complications ; Palliative Care ; Stents / adverse effects ; Treatment Outcome
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 benefits regarding stent patency and overall survival, although PCDBSs have a lower rate of tumor ingrowth. (Clinical trial registration number: NCT02937246.).
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Seung Woo(박승우) ORCID logo https://orcid.org/0000-0001-8230-964X
Park, Jeong Youp(박정엽) ORCID logo https://orcid.org/0000-0003-0110-8606
Bang, Seungmin(방승민) ORCID logo https://orcid.org/0000-0001-5209-8351
Song, Si Young(송시영) ORCID logo https://orcid.org/0000-0002-1417-4314
Lee, Hee Seung(이희승) ORCID logo https://orcid.org/0000-0002-2825-3160
Chung, Moon Jae(정문재) ORCID logo https://orcid.org/0000-0002-5920-8549
Cho, Jae Hee(조재희) ORCID logo https://orcid.org/0000-0003-4174-0091
Jo, Jung Hyun(조중현) ORCID logo https://orcid.org/0000-0002-2641-8873
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