内镜支架引流治疗不可切除肝门胆管恶性梗阻临床成功影响因素的多中心研究

Influencing factors for the clinical success of endoscopic stent drainage for unresectable malignant hilar obstruction: a multicenter study

摘要:

目的 探讨不可切除的肝门胆管恶性梗阻患者行内镜支架引流临床成功的影响因素。方法 回顾性分析2002年1月至2019年1月期间在3所内镜中心（海军军医大学第三附属医院502例、空军军医大学西京医院92例和上海交通大学附属第一人民医院39例）成功接受支架引流的肝门胆管恶性梗阻（Bismuth Ⅱ~Ⅳ型）的633例患者资料。主要观察指标为临床成功率，次要观察指标为支架通畅期和总体生存时间。临床成功患者和临床失败患者单因素比较中P<0.1的变量，纳入多因素logistic 回归，筛选出患者临床成功的独立影响因素。临床成功患者和临床失败患者支架通畅期和总体生存期使用Kaplan‑Meier曲线展示，两组间的差异比较使用log‑rank方法。结果 共有503例患者临床引流成功，有130例患者临床引流失败，总体患者的临床成功率为79.5%。单因素分析显示性别、疾病类型、Bismuth分型、肝硬化、支架类型、支架数量、支架跨越十二指肠乳头和肝脏引流体积可能是影响引流临床成功的因素（P<0.05）。进一步的多因素回归分析确定Bismuth分型（Bismuth Ⅱ~Ⅲ型比Bismuth Ⅳ型：OR=3.308，95%CI：1.772~6.176，P<0.001）、支架类型（金属比塑料：OR=3.297，95%CI：1.829~5.942，P<0.001）和支架数量（双边比单边：OR=2.335，95%CI：1.463~3.727，P<0.001）均为引流临床成功的独立预测因素。临床成功和临床失败患者的支架通畅期分别为6.5（95%CI：5.6~7.4）个月和1.2（95%CI：0.9~1.5）个月（P<0.001），生存时间分别为5.1（95%CI：4.6~5.6）个月和1.2（95%CI：0.9~1.6）个月（P<0.001）。结论 内镜支架引流治疗不可切除的肝门胆管恶性梗阻患者时，Bismuth Ⅳ型的患者临床成功率较低； 使用金属支架或者双边引流的患者可以提高临床成功率。

Abstract:

Objective To investigate the factors influencing the clinical success of endoscopic stent drainage in patients with unresectable malignant hilar obstruction. Methods Data of 633 patients with malignant hilar obstruction (Bismuth Ⅱ‑Ⅳ) who successfully received stent placement in the Third Affiliated Hospital of Naval Medical University (n=502), the First Affiliated Hospital of Air Force Medical University (n=92), the First People''s Hospital Affiliated to Shanghai Jiao Tong University (n=39) from January 2002 to January 2019 were retrospectively analyzed. The primary outcome was clinical success rate, while the secondary outcomes were stent patency and overall survival time. The variables with a P‑value<0.1 in the univariate comparison between clinically successful patients and clinically unsuccessful patients were included in the multivariate logistic regression to further determine independent influencing factors for clinical success in patients. The stent patency and overall survival of clinically successful and clinically failed patients were demonstrated using Kaplan‑Meier curve, and the differences between the two groups were compared using the log‑rank method. Results A total of 503 patients achieved clinical drainage success, with 130 patients experiencing clinical drainage failure. The overall clinical success rate of patients was 79.5%. Univariate analysis showed that gender, disease type, Bismuth classification, cirrhosis, stent type, number of stents, stent crossing duodenal papilla, and liver drainage volume might be factors that affected drainage clinical success (P<0.05). Further multivariate regression analysis confirmed that Bismuth typing (Bismuth Ⅱ‑Ⅲ type VS Bismuth Ⅳ type: OR=3.308, 95%CI: 1.772‑6.176, P<0.001), stent type (metal stent VS plastic stent: OR=3.297, 95%CI: 1.829‑5.942, P<0.001), and stent quantity (bilateral VS unilateral: OR=2.335, 95%CI: 1.463‑3.727, P<0.001) were all independent predictors for drainage clinical success. The stent patency was 6.5 (95%CI:5.6‑7.4) months in clinically successful patients and 1.2 (95%CI: 0.9‑1.5) months in clinically unsuccessful patients (P<0.001), and the survival time was 5.1 (95%CI:4.6‑5.6) months in clinically successful patients and 1.2 (95%CI:0.9‑1.6) months in clinically unsuccessful patients (P<0.001), respectively. Conclusion The clinical success rate of endoscopic stent drainage for inoperable malignant hilar obstruction is low in Bismuth type Ⅳ patients, and metal stent or bilateral drainage can improve clinical success.