Prospective multicenter evaluation of moving cell metallic stents in endoscopic multiple stent deployment for hepatic hilar obstruction.

Background And Aim: Bilateral stent deployment for malignant biliary obstruction (MHBO) can be achieved using side-by-side (SBS) or stent-in-stent (SIS) procedures. Compared with SBS techniques, the procedural steps of SIS are technically complex due to the necessity of introducing the delivery system into a contralateral biliary tract through the mesh of the SEMS. To overcome this issue, a novel uncovered SEMS, the HILZO Moving Cell Stent (MCS) has been released. The present study examined the technical feasibility of treating MHBO using bilateral deployment of this novel stent without dilating the mesh of the first stent to achieve insertion of the second stent within a single session, using a prospective, multicenter setting.

Method: The primary outcome in the present study was the technical success rate. Technical success was defined as deployment of bilateral MCSs into two or more biliary tracts using SIS without a dilation device in a single-session.

Results: A total of 27 patients with complications of MHBO were enrolled in this study. Bilateral SIS using two MCS was successfully performed in 23 patients without using dilation devices among 27 patients (initial technical success rate; 85.2%). Median time to recurrent biliary obstruction (TRBO) was 271 days. Stent dysfunction was observed in 12 patients (44.4%), and re-intervention was successfully performed in all patients without one patient who instead received best supportive care.

Conclusions: The SIS technique using MCS without dilation of the mesh may be technically feasible and safe. In addition, this may be useful for re-intervention. Further comparative randomized trials are needed.