Xiang Yucheng, Lu Sinan, Li Yufeng, Liu Zhenghao, Wang Weilin
Department of Hepatobiliary and Pancreatic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009.
Key Laboratory of Precision Diagnosis and Treatment for Hepatobiliary and Pancreatic Tumor of Zhejiang Province, Hangzhou, Zhejiang 310009.
J Cancer. 2021 Jan 1;12(5):1334-1342. doi: 10.7150/jca.49663. eCollection 2021.
Malignant biliary obstruction is always caused by tumors which are unresectable so that palliative stent placement is conducted for drainage of bile duct tree. Recently, irradiation stent with I seeds has been used to improve the stent patency and survival time of patients. We conducted this meta-analysis to evaluate the therapeutic efficacy and safety of biliary stent placement with I seeds compared with stent placement alone in patients with malignant biliary obstruction. We searched Pubmed, Web of Science, ClinicalTrials.gov, Cochrane Library, Embase and CNKI databases for all relevant studies up to 1 May 2020. Patient survival, stent patency, and adverse events were the primary outcome measured. Also, Review Manager 5.3 and Stata/SE15.0 were used to perform the analysis. Eleven randomized controlled trials with a total of 767 patients were included for meta-analysis. Stent combined with I seeds showed lower risk of stent occlusion at 3 month (Odds Ratios(OR) = 0.15; 95%CI: 0.05-0.49, =0.002), 6 month (OR = 0.18; 95%CI: 0.08-0.44, = 0.0001), 9 month (OR = 0.10; 95%CI: 0.05-0.20, < 0.00001) and 1 year (OR = 0.15; 95%CI: 0.07-0.31, < 0.00001) and better mean survival (MD = 125days; 95% CI 91-159 days; P < 0.00001) compared with stent placement alone. Also, reconstructed Kaplan-Meier data demonstrated improved survival in patients treated with stent plus I seeds (hazard ratio(HR)= 1.886; 95% CI: 1.609 to 2.210; P < 0.0001) Moreover, our analysis did not show significant difference between the two groups about the risk of adverse events including abdominal pain, hemobilia, pancreatitis, cholangitis and cholecystitis. I seeds combined with stent demonstrated superior stent patency and improved survival time compared to stent alone with acceptable complications.
恶性胆管梗阻总是由无法切除的肿瘤引起，因此需进行姑息性支架置入以引流胆管树。最近，含碘粒子的放射性支架已被用于提高支架通畅率和患者生存时间。我们进行这项荟萃分析，以评估在恶性胆管梗阻患者中，与单纯支架置入相比，含碘粒子胆管支架置入的治疗效果和安全性。我们检索了截至2020年5月1日的Pubmed、Web of Science、ClinicalTrials.gov、Cochrane图书馆、Embase和中国知网数据库中的所有相关研究。患者生存、支架通畅和不良事件是主要测量结果。此外，使用Review Manager 5.3和Stata/SE15.0进行分析。共纳入11项随机对照试验，总计767例患者进行荟萃分析。与单纯支架置入相比，支架联合含碘粒子在3个月（比值比（OR）=0.15；95%置信区间：0.05 - 0.49，P = 0.002）、6个月（OR = 0.18；95%置信区间：0.08 - 0.44，P = 0.0001）、9个月（OR = 0.10；95%置信区间：0.05 - 0.20，P < 0.00001）和1年（OR = 0.15；95%置信区间：0.07 - 0.31，P < 0.00001）时支架闭塞风险更低，平均生存期更长（MD = 125天；95%置信区间91 - 159天；P < 0.00001）。此外，重建的Kaplan - Meier数据显示，支架加含碘粒子治疗的患者生存期有所改善（风险比（HR）= 1.886；95%置信区间：1.609至2.210；P < 0.0001）。此外，我们的分析未显示两组在腹痛、胆道出血、胰腺炎、胆管炎和胆囊炎等不良事件风险方面存在显著差异。与单纯支架相比，含碘粒子联合支架显示出更好的支架通畅率和更长的生存时间，且并发症可接受。
