Center for Endoscopic Research and Therapeutics, Section of Gastroenterology, Department of Medicine, University of Chicago Medical Center, Chicago, Illinois 60637, USA.
Gastrointest Endosc. 2010 Sep;72(3):632-6. doi: 10.1016/j.gie.2010.04.037. Epub 2010 Jun 26.
A 6F endoscopic biliary self-expanding metal stent (SEMS) has been newly introduced for intended simultaneous side-by-side bilateral deployment in hilar malignant obstruction.
To report our initial experience with the Zilver 635 biliary SEMS.
Retrospective chart review.
Tertiary referral medical center.
Sixteen consecutive malignant hilar biliary obstruction patients.
Endoscopic palliative treatment of malignant biliary obstruction with the Zilver 635 SEMS from December 2008 to January 2010.
Technical/functional success rates, early complications (within 30 days of stent placement), early/late stent occlusion, and biliary reintervention rates.
A total of 49 Zilver SEMSs were placed in 16 patients (mean age 61 years, 6 men) for Bismuth type II (n = 4), III (n = 5), and IV (n = 7) lesions. Twelve had cholangiocarcinoma, 2 had metastatic colon cancer, 1 had lung cancer, and 1 had pancreatic cancer. The technical success rate was 100%. Side-by-side simultaneous bilateral stent deployment was required and was achieved successfully in 10 cases. Additional transpapillary stents were placed for potential future biliary access. The 30-day mortality rate was 0%. There were 1 early (6%) and 3 late (19%) stent occlusions. Successful overall biliary drainage was 75%.
Small sample size, uncontrolled retrospective study.
Malignant hilar biliary obstruction endoscopic palliation with the Zilver 635 SEMS offers acceptable initial feasibility, safety, and efficacy profiles. The current design facilitates smaller bile duct negotiation and more precise intrahepatic placement. Expanding available lengths would allow transpapillary bridged bilateral SEMS placement for future reobstructed biliary access. Further long-term studies are required for comparative outcomes with other current SEMS technology.
一种新型的 6F 内镜下胆道自膨式金属支架（SEMS）已被引入，用于预期在肝门恶性梗阻时同时进行双侧并列部署。
报告我们使用 Zilver 635 胆道 SEMS 的初步经验。
回顾性图表审查。
三级转诊医疗中心。
16 例连续的恶性肝门胆管梗阻患者。
使用 Zilver 635 SEMS 对 2008 年 12 月至 2010 年 1 月的恶性胆道梗阻进行内镜姑息治疗。
技术/功能成功率、早期并发症（支架放置后 30 天内）、早期/晚期支架阻塞和胆道再介入率。
16 例患者共放置了 49 个 Zilver SEMS（平均年龄 61 岁，6 名男性），Bismuth 类型 II（n = 4）、III（n = 5）和 IV（n = 7）病变。12 例为胆管癌，2 例为转移性结肠癌，1 例为肺癌，1 例为胰腺癌。技术成功率为 100%。需要并成功地进行了 10 例双侧并列同时支架部署。另外放置了经乳头支架，以备将来可能进行胆道介入。30 天死亡率为 0%。有 1 例（6%）早期和 3 例（19%）晚期支架阻塞。总的胆道引流成功率为 75%。
样本量小，非对照回顾性研究。
使用 Zilver 635 SEMS 进行恶性肝门胆管梗阻的内镜姑息治疗具有可接受的初始可行性、安全性和疗效。当前的设计便于较小的胆管协商和更精确的肝内放置。扩大可用长度将允许经乳头桥接双侧 SEMS 放置，以备将来再阻塞的胆道进入。需要进一步的长期研究来比较与其他当前 SEMS 技术的结果。
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