Nanashima Atsushi, Hiyoshi Masahide, Imamura Naoya, Hamada Takeomi, Nishida Takahiro, Kawakami Hiroshi, Ban Tesshin, Kubota Yoshimasa, Nakashima Koji, Yano Koichi, Wada Takashi, Takeno Shinsuke, Kai Masahiro
Division of Hepato-Biliary-Pancreas Surgery, Department of Surgery, University of Miyazaki Faculty of Medicine, 5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan.
Division of Gastrointestinal, Endocrine and Pediatric Surgery, Department of Surgery, University of Miyazaki Faculty of Medicine, Miyazaki, Japan.
Clin J Gastroenterol. 2020 Feb;13(1):102-109. doi: 10.1007/s12328-019-01006-5. Epub 2019 Jun 20.
The efficacy of adjuvant photodynamic therapy (PDT) using the new photosensitizer, talaporfin sodium (TPS) has been clinically examined in some patients with bile duct carcinoma (BDC). Based on our previous cohorts, a prospective clinical trial was attempted; however, only two cases were ultimately enrolled in 27 months. A 664-nm semiconductor laser (100 J/cm) was applied through an endoscope to the tumor lesion within 6 h of an intravenous injection of 40 mg/m TPS according to the protocol for lung cancer. Case 1 was an 82-y.o. female patient with BDC at the left hepatic duct with biliary obstruction, percutaneous transhepatic biliary drainage (PTBD) was achieved, and the patient did not consent to surgery. She was followed up for 15 months to search for non-surgical treatments and eventually received PDT. Although mild photosensitivity occurred, she was discharged without severe adverse events. Biliary stenosis markedly extended and a PTBD tube was scheduled at 1 month. However, cancer immediately metastasized to the liver and she died 155 days after PDT. Case 2 was a 70-y.o. female with perihilar BDC and multiple biliary stenoses. Multiple biliary stenting was considered to be difficult. She received PDT and no adverse events were observed. Biliary stenoses markedly improved and multiple stenting was successfully performed. On day 132, she died of cancer progression. These two cases demonstrated the safety and efficacy of biliary malignant stenosis soon after PDT; however, long-term survival and a sufficient quality of life were not achieved. The combination of the PDT protocol and system chemotherapy or brachytherapy needs to be examined in clinical trials for advanced stage BDC.
新型光敏剂替拉泊芬钠（TPS）辅助光动力疗法（PDT）在部分胆管癌（BDC）患者中的疗效已得到临床检验。基于我们之前的队列研究，尝试开展一项前瞻性临床试验；然而，在27个月内最终仅纳入了2例患者。根据肺癌治疗方案，在静脉注射40mg/m² TPS后6小时内，通过内镜将664nm半导体激光（100J/cm²）照射至肿瘤病灶。病例1是一名82岁女性BDC患者，左肝管存在胆道梗阻，已成功实施经皮经肝胆道引流（PTBD），患者不同意手术。为寻找非手术治疗方法对其进行了15个月的随访，最终接受了PDT治疗。尽管出现了轻度光敏反应，但她出院时未发生严重不良事件。胆管狭窄明显加重，计划在1个月时置入PTBD管。然而，癌症随即转移至肝脏，她在PDT治疗后155天死亡。病例2是一名70岁女性，患有肝门周围BDC和多处胆管狭窄。考虑难以进行多处胆管支架置入。她接受了PDT治疗，未观察到不良事件。胆管狭窄明显改善，并成功进行了多处支架置入。在第132天，她因癌症进展死亡。这两个病例证明了PDT治疗后不久对胆管恶性狭窄的安全性和有效性；然而，未实现长期生存和足够的生活质量。对于晚期BDC，需要在临床试验中检验PDT方案与系统化疗或近距离放疗的联合应用。
