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
Processing time: 154 Days and 8.4 Hours
Abstract
BACKGROUND

Percutaneous bilateral biliary stenting is an established method for the management of unresectable malignant hilar biliary obstruction.

AIM

To evaluate the efficacy and safety of a novel uncovered biliary stent, specifically designed for hilar reconstruction.

METHODS

This, single-center, retrospective study included 18 patients (mean age 71 ± 11 years; 61.1% male) undergoing percutaneous transhepatic Moving cell stent (MCS) placement for hilar reconstruction using the stent-in-stent technique for malignant biliary strictures, between November 2020 and July 2021. The Patients were diagnosed with cholangiocarcinoma (12/18; 66.6%), gallbladder cancer (5/18; 27.7%), and colorectal liver metastasis (1/18; 5.5%). Primary endpoints were technical (appropriate stent placement) and clinical (relief from jaundice) success. Secondary endpoints included stent patency, overall survival, complication rates and stent-related complications.

RESULTS

The technical and clinical success rates were 100% (18/18 cases). 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. The mean stent patency was 172.53 ± 56.20 d and median stent patency was 165 d (range 83-315). Laboratory tests for cholestasis significantly improved after procedure: mean total bilirubin decreased from 15.2 ± 6.0 mg/dL to 1.3 ± 0.4 mg/dL (P < 0.001); mean γGT decreased from 1389 ± 832 U/L to 114.6 ± 53.5 U/L (P < 0.001). One periprocedural complication was reported. Stent-related complications were observed in 5 patients (27.7%), including 1 occlusion (5.5%) and 1 stent migration (5.5 %).

CONCLUSION

Percutaneous hilar bifurcation biliary stenting with the MCS resulted in excellent clinical and technical success rates, with acceptable complication rates. Further studies are needed to confirm these initial positive results.

Keywords: Malignant hilar biliary obstructions; Hilar cholangiocarcinoma; Self-expandable metallic stent; Stent-in-stent technique; Percutaneous approach; Bilateral Y-stenting

Core Tip: This single-center, retrospective study investigated eighteen patients with unresectable malignant hilar biliary obstructions treated with a novel uncovered biliary metallic stent [Moving Cell 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. The study results indicate that percutaneous MCS placement using stent-in-stent technique is feasible and safe. Comparison with other stents demonstrated superiority in both stent patency and technical success.