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Cross-wired metal stents for endoscopic bilateral stent-in-stent deployment in malignant hilar biliary obstruction: A multicenter, single-arm, prospective study
- Source :
- DEN open. 2(1)
- Publication Year :
- 2021
-
Abstract
- The endoscopic bilateral stent-in-stent (SIS) deployment is a challenging procedure. Such difficulty is mainly caused by sticking of the tip of the delivery sheath into the self-expandable metal stents (SEMSs) mesh, requiring an additional dilating procedure. Herein, we assessed the clinical results of using cross-wired metal stent for endoscopic bilateral SIS deployment (BONASTENT M-Hilar) in patients with malignant hilar biliary obstruction (MHBO) in both high-volume and non-high-volume centers.We prospectively enrolled consecutive patients with MHBO between February 2016 and December 2018 at eight centers.Forty-six patients were enrolled during the study period. The proportions of technical success were 93.5% (43/46) and clinical success (CS) on intention-to-treat and per-protocol analyses were 91.3% (42/46) and 93.0% (40/43), respectively. The proportion of an additional dilating procedure during the primary procedure was 50.0% (23/46). Recurrent biliary obstruction (RBO) on intention-to-treat analysis occurred in 32.6% (15/46) of cases. Almost all of the events were caused by stent ingrowth (14/15). The median survival time and time to RBO were 255 and 349 days, respectively. The probability of stent patency at 3, 6, and 12 months was 86.5%, 63.9%, and 47.6%, respectively.The cross-wired metal stent had excellent technical and CS, although non-high-volume centers were included in this study (UMIN000021441).
Details
- ISSN :
- 26924609
- Volume :
- 2
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- DEN open
- Accession number :
- edsair.doi.dedup.....7ce9cbfe2241331a75740c362534de4f