Observational Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Sep 15, 2022; 14(9): 1833-1843
Published online Sep 15, 2022. doi: 10.4251/wjgo.v14.i9.1833
Percutaneous insertion of a novel dedicated metal stent to treat malignant hilar biliary obstruction
Francesco Cortese, Fabrizio Acquafredda, Andrea Mardighian, Maria Teresa Zurlo, Valentina Ferraro, Riccardo Memeo, Stavros Spiliopoulos, Riccardo Inchingolo
Francesco Cortese, Fabrizio Acquafredda, Andrea Mardighian, Maria Teresa Zurlo, Riccardo Inchingolo, Interventional Radiology Unit, Miulli Hospital, Acquaviva Delle Fonti 70124, Italy
Valentina Ferraro, Riccardo Memeo, Unit of Hepatobiliary Surgery, Miulli hospital, Acquaviva Delle Fonti 70124, Italy
Stavros Spiliopoulos, 2nd Radiology Department, National and Kapodistrian University of Athens, Chaidari Athens 12461, Greece
Author contributions: Cortese F, Acquafredda F, Mardighian A, Zurlo MT, Ferraro V, Memeo R, Spiliopoulos S, Inchingolo R equally contributed to this paper with conception and design of the study, literature review and analysis, drafting and critical revision and editing, and final approval of the final version.
Institutional review board statement: The study was reviewed and approved by the independent ethics committee of University Hospital Company “Consorziale Policlinico” of Bari, No 7083.
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used clinical data that were obtained after each patient agreed to treatment by written consent.
Conflict-of-interest statement: There are no conflicts of interest to report.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at riccardoin@hotmail.it. Consent was not obtained but the presented data are anonymized and risk of identification is low.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Riccardo Inchingolo, MD, Chief Doctor, Director, Doctor, Interventional Radiology Unit, Miulli Hospital, Strada per santeramo, Acquaviva Delle Fonti 70123, Italy. riccardoin@hotmail.it
Received: April 8, 2022
Peer-review started: April 8, 2022
First decision: May 11, 2022
Revised: June 11, 2022
Accepted: August 21, 2022
Article in press: August 21, 2022
Published online: September 15, 2022
ARTICLE HIGHLIGHTS
Research background

The treatment of malignant hilar biliary obstruction is very difficult because patients are often not suitable for surgery, therefore palliative care plays a pivotal role.

Research motivation

According to the literature, there are only two previously published studies both investigating endoscopic bilateral Y-stenting using the, therefore this is the first study investigating percutaneous placement of Moving Cell Stent (MCS).

Research objectives

To evaluate the efficacy and safety of a novel uncovered biliary stent, specifically designed for hilar reconstruction in patients with unresectable malignant hilar biliary obstructions.

Research methods

A retrospective, single-centre study was performed, investigating 18 patients with unresectable malignant hilar biliary obstructions treated with a novel uncovered biliary metallic stent (MCS; BCM Co., Ltd., Gyeonggi-do, South Korea), specifically designed for hilar reconstruction, using stent-in-stent technique via percutaneous approach. Primary endpoints were clinical and technical success.

Research results

The technical and clinical success rates were 100%. One periprocedural complication was reported. Stent-related complications were observed in 5 patients. According to Kaplan-Meier analysis, the estimated overall patient survival was 80.5% and 60.4% at 6 and 12 mo respectively, while stent patency was 90.9% and 68.2% at 6 mo and 12 mo respectively.

Research conclusions

For patients with unresectable malignant hilar biliary obstruction using percutaneous placement with the stent-in-stent technique was a feasible and safe and resulted in excellent technical and clinical success rates. Periprocedural and stent-related complications were acceptable.

Research perspectives

Since MCS is a recently introduced stent, prospective, multicentre, randomized trials are needed to verify these initial promising results.