Successful photodynamic therapy for nonresectable cholangiocarcinoma:: A randomized prospective study
Successful photodynamic therapy for nonresectable cholangiocarcinoma:: A randomized prospective study
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DOI：
10.1016/j.gastro.2003.07.015
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发表时间：
2003-11-01
期刊：
影响因子：
29.4
通讯作者：
Lochs, H
中科院分区：
文献类型：
--
作者：
Ortner, MEJ;Caca, K;Lochs, H
背景与目的：在非随机试验中，光动力疗法（PDT）对不可切除的胆管癌（NCC）有很好的疗效。这项前瞻性、开放标签、随机、多中心的研究采用组序贯设计，比较了PDT +支架置入（a组）与单纯支架置入（B组）对NCC患者的影响。方法：对经组织学证实的胆管癌患者行内镜下或经皮双支架置入。符合纳入标准的患者被随机分为A组（支架置入和随后的PDT）和B组（单独支架置入）。对于PDT，在腔内光激活前2天静脉注射Photofrin 2 mg/kg体wt（波长630 nm；光剂量180 J/cm(2)）。胆管内肿瘤残留的病例进行进一步治疗。主要结局参数为生存时间。次要结局参数为胆汁淤积和生活质量。结果：PDT延长生存期（A组：in = 20，中位493天；B组：n = 19，中位98天；P < 0.0001）。它还改善了胆道引流和生活质量。结论：在最佳支持治疗的基础上给予PDT，可提高NCC患者的生存率。该研究被提前终止，因为PDT被证明优于简单支架治疗，进一步的随机化被认为是不道德的。
Background & Aims: In nonrandomized trials, photodynamic therapy (PDT) had a promising effect on nonresectable cholanglocarcinoma (NCC). This prospective, open-label, randomized, multicenter study with a group sequential design compared PDT in addition to stenting (group A) with stenting alone (group B) in patients with NCC. Methods: In patients with histologically confirmed cholangiocarcinoma, endoscopic or percutaneous double stenting was performed. Patients fulfilling inclusion criteria were randomized to group A (stenting and subsequent PDT) and group B (stenting alone). For PDT, Photofrin 2 mg/kg body wt was injected intravenously 2 days before intraluminal photoactivation (wavelength, 630 nm; light dose, 180 J/cm(2)). Further treatments were performed in cases of residual tumor in the bile duct. The primary outcome parameter was survival time. Secondary outcome parameters were cholestasis and quality of life. Results: PDT resulted in prolongation of survival (group A: In = 20, median 493 days; group B: n = :19, median 98 days; P < 0.0001). It also improved biliary drainage and quality of life. Conclusions: PDT, given in addition to best supportive care, improves survival in patients with NCC. The study was terminated prematurely because PDT proved to be so superior to simple stenting treatment that further randomization was deemed unethical.