Y型嵌合内支架植入治疗肝门部恶性胆道梗阻的初步临床应用

Primary clinical application of Y-shaped jogged stent in patients with malignant hilar biliary obstruction

目的 探讨Y型嵌合内支架植入治疗肝门部恶性胆道梗阻的可行性、安全性及有效性.方法 回顾性分析2010年1月至2015年6月,98例经内支架植入治疗的肝门部恶性胆道梗阻患者临床资料.其中在2012年1月至2015年6月,植入Y型嵌合内支架的患者17例（A组）,根据患者的年龄、性别、肿瘤类型及分期、胆道梗阻分型、诊断时胆红素水平、是否有转移及治疗,对A组进行严格的配对（两组患者这些指标差异无统计学意义,P值均〉0.05）,选取17例一侧行单支架植入联合另一侧行经皮肝穿刺胆道置管引流术患者作为对照组（B组）.分析两组患者的一般资料、支架植入策略、相关并发症、术后支架畅通时间及生存时间等情况.组间比较,符合正态分布的计量资料采用t检验,计数资料采用Fisher检验.结果 A组患者Y型嵌合内支架植入及B组患者一侧单支架植入联合另一侧胆道置管引流术的手术均成功.A、B组患者术后1周血清胆红素下降率分别为88.2%和53.0%,支架植入术后平均通畅时间分别为（7.3±1.0）个月和（5.7±0.9）个月（χ2=4.04）,平均生存时间分别为（9.1±1.5）个月和（7.2±1.1）个月（χ2=4.60,P值均〈0.05）.所有患者均未出现与支架植入有关的胆道大出血、穿孔、胆瘘及重症胰腺炎等并发症及死亡病例.结论 Y型嵌合内支架植入可有效解除肝门部恶性胆道梗阻患者的临床症状,技术可行、安全,近期疗效可靠,且胆道Y型嵌合内支架的通畅时间及患者的生存期明显延长.

Objective To evaluate the feasibility, safety, and efficacy of Y-shaped jogged stent in patients with malignant hilar biliary obstruction. Methods During the period of January 2010 to June 2015,We retrospectively reviewed 98 cases of malignant hilar biliary obstruction who were received implantation of biliary tract stent. 17 consecutive patients who were treated with Y-shaped jogged stent were identified （group A） during January 2012 to June 2015. Group A was carefully matched according to patients＇s age, sex, type of tumor, stage, type of biliary obstruction, level of bilirubin at diagnosis, presence of metastasis and treatment, and 17 patients who were underwent unilateral stent placement alone with PTCD were chosen as control group （group B）. Patients＇s baseline characteristics, stenting strategy, complications, stent patency time and survival rates were analyzed, and continuous variables of the two groups were compared using Student＇s t-test. Categorical variables were analyzed using the Fisher exact test. Results Y-shaped jogged stent implantation group and control groups were closely matched in terms of patients＇s age, sex, type of tumor, stage, type of biliary obstruction, level of bilirubin at diagnosis, presence of metastasis and treatment （ P〉0.05）. The bilirubin decreased rate in the two groups was 88.2%and 53.0%respectively （P〈0.05）. The median time of stent patency after stent implantation was（7.3 ± 1.0）months and（5.7 ± 0.9） months respectively （χ^2=4.04,P=0.044）, and the median survival time was（9.1 ± 1.5）months and（7.2 ± 1.1）months （χ^2=4.60,P=0.032）, with significant difference according to Kaplan-Meier analysis. There were no severe complications such as massive hemorrhage, perforation, biliary fistula and severe pancreatitis, which were associated with stent implantation. Conclusions The application of Y-shaped jogged stent is safe, feasible and effective in patients with malignant hilar biliary obstruction. It can relieve the clinical symptoms of biliary obstruction effectively with prolongation of stent patency time and survival rate significantly.