The Feasibility of Whole-Liver Drainage with a Novel 8 mm Fully Covered Self-Expandable Metal Stent Possessing an Ultra-Slim Introducer for Malignant Hilar Biliary Obstructions

Abstract

Background: In the case of an unresectable malignant hilar biliary obstruction (MHBO), the optimal drainage method has not yet been established. Recently, an 8 mm, fully covered, self-expandable metal stent (FCSEMS) with an ultra-slim introducer has become available. In this article, the results of whole-liver drainage tests using this novel FCSEMS for MHBO are reported. Methods: Unresectable MHBOs up to Bismuth IIIa with strictures limited to the secondary branches were eligible. The proximal end of the stent was placed in such a way as to avoid blocking the side branches, and the distal end was placed above the papilla when possible. Consecutive patients treated between April 2017 and January 2021 were retrospectively analyzed. The technical and functional success rates, rates and causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), revision for RBO, and adverse events (AEs) were evaluated. Results: Eleven patients (Bismuth I/II/IIIa: 1/7/3) were enrolled. Two stents were placed in nine patients and three were placed in two patients. Both the technical and functional success rates were 100%. RBO occurred in four (36%) patients due to sludge formation. Revision was performed for three patients, with the successful removal of all stents. The median TRBO was 187 days, and no late AEs other than the RBO occurred. Regarding the distal position of the stent, the RBO rate was significantly lower (14.3% vs. 75%, p = 0.041) and the cumulative TRBO was significantly longer (median TRBO: not reached vs. 80 days, p = 0.031) in the case of the placement above the papilla than the placement across the papilla. Conclusion: For unresectable MHBOs of Bismuth I, II, and IIIa, whole-liver drainage with a novel 8 mm FCSEMS possessing an ultra-slim introducer was feasible and potentially safe, with favorable stent patency. Placement above the papilla might be preferrable to placement across the papilla.

Endoscopic Treatment of Malignant Hilar Biliary Obstruction

“…With recent developments in chemotherapy and prolonging survival of patients with MHBO (for example with CCA) stenting with UCSEMS is becoming a suboptimal strategy due to tumor overgrowth by the wire mesh of UCSEMS and the inability to replace the stent (Table 2.). To date, there have been only five studies published evaluating the use of FCSEMS in MHBO (Inoue et al [33], Yoshida et al [38], Kitamura et al [39], Takahashi et al [40], Matsubara et al [41]). Each one has shown high technical and clinical success rates and the high success rate of endoscopic re-intervention.…”

Clinical Advances in the Diagnosis and Treatment of Biliary Tract Diseases

“…However, recent advances in chemotherapy have prolonged survival and increased the chance of stent occlusion, and unremovable UCSEMS have become a problematic barrier to reintervention. A fully covered SEMS (FCSEMS) can be removed and is expected to have a good patency period due to its larger diameter compared to a plastic stent [ 8 ], but there is still little evidence, so future large-scale clinical trials are needed.…”