Gao Dao-Jian, Xing Ling, Ye Xin, Wang Tian-Tian, Wu Jun, Xia Ming-Xing, Hu Bing
Department of Endoscopy, Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University, 225 Changhai Road, Shanghai, 200438, People's Republic of China.
Dig Dis Sci. 2022 Mar;67(3):1073-1082. doi: 10.1007/s10620-021-06906-6. Epub 2021 Mar 6.
Bilateral endoscopic biliary stenting remains technically challenging, which limits its wider clinical application.
We have developed a novel long (10-12 cm) and slimmer (6 mm) self-expanded metal stent. The aim of this study was to evaluate the feasibility, efficacy, and safety of the new metal stent for palliative treatment of malignant hilar biliary strictures (MHBS).
This retrospective study of prospectively collected data included 45 patients with unresectable malignant hilar biliary strictures of Bismuth type II or higher. A pair of long slimmer metal stents were sequentially placed into the intrahepatic duct using the stent-by-stent mode. The success rate and short- and long-term clinical outcomes were observed.
The technical success rate was 100%, with a mean procedure time of 43.7 ± 11.5 min. The clinical success was achieved in 44 patients (97.8%). Early adverse events included mild acute pancreatitis (n = 2) and cholangitis (n = 3). Later cholangitis occurred in 14 of the 45 patients due to stent occlusions. The median stent patency was 260 days (95% CI 228.3-291.7). Stent malfunctions occurred in 23 of the 45 patients, and 15 of them received bilateral endoscopic plastic stents placements. The technical success for the re-intervention was 100% with the mean procedure time of 24.3 ± 4.5 min. The median overall survival of the whole group was 229 days (95% CI 171.2-286.8).
The long slimmer metal stent for bilateral endoscopic stent-by-stent placement proved to be safe, feasible, and effective for MHBS and facilitates endoscopic re-intervention as well.
双侧内镜下胆管支架置入术在技术上仍然具有挑战性，这限制了其更广泛的临床应用。
我们研发了一种新型的长（10 - 12厘米）且更细（6毫米）的自膨式金属支架。本研究的目的是评估这种新型金属支架用于恶性肝门部胆管狭窄（MHBS）姑息治疗的可行性、有效性和安全性。
这项对前瞻性收集数据的回顾性研究纳入了45例无法切除的铋氏II型或更高类型的恶性肝门部胆管狭窄患者。采用逐个支架模式将一对长且细的金属支架依次置入肝内胆管。观察成功率以及短期和长期临床结果。
技术成功率为100%，平均手术时间为43.7±11.5分钟。44例患者（97.8%）获得临床成功。早期不良事件包括轻度急性胰腺炎（n = 2）和胆管炎（n = 3）。45例患者中有14例因支架堵塞出现后期胆管炎。支架中位通畅时间为260天（95%可信区间228.3 - 291.7）。45例患者中有23例出现支架故障，其中15例接受了双侧内镜下塑料支架置入术。再次干预的技术成功率为100%，平均手术时间为24.3±4.5分钟。全组患者的中位总生存期为229天（95%可信区间171.2 - 286.8）。
用于双侧内镜逐个支架置入的长且细的金属支架被证明对MHBS安全、可行且有效，并且也便于内镜再次干预。
