Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Institute for Liver and Digestive Health, University College London, London, UK.
Gastrointest Endosc. 2021 Jul;94(1):179-186. doi: 10.1016/j.gie.2021.02.027. Epub 2021 Feb 26.
Locally advanced pancreatic cancer (LAPC) often causes obstruction. Verteporfin photodynamic therapy (PDT) can feasibly "debulk" the tumor more safely than noncurative surgery and has multiple advantages over older PDT agents. We aimed to assess the feasibility of EUS-guided verteporfin PDT in ablating nonresectable LAPC.
Adults with LAPC with adequate biliary drainage were prospectively enrolled. Exclusion criteria were significant metastatic disease burden, disease involving >50% duodenal or major artery circumference, and recent treatment with curative intent. CT was obtained between days -28 to 0. On day 0, verteporfin .4 mg/kg was infused 60 to 90 minutes before EUS, during which a diffuser was positioned in the tumor and delivered light at 50 J/cm for 333 seconds. CT was obtained on day 2, with adverse event monitoring occurring on days 1, 2, and 14. The primary outcome was presence of necrosis.
Of 8 patients (62.5% men, mean age 65 ± 7.9 years) included in the study, 5 were staged at T3, 2 at T2, and 1 at T1. Most (n = 4) had primary lesions in the pancreatic head. Mean pretrial tumor diameter was 33.3 ± 13.4 mm. On day 2 CT, 5 lesions demonstrated a zone of necrosis measuring a mean diameter of 15.7 ± 5.5 mm; 3 cases did not develop necrosis. No adverse events were noted during the procedure or postprocedure observation period (days 1-3), and no changes in patient-reported outcomes were noted.
In this pilot study, EUS-guided verteporfin PDT is feasible and shows promise as a minimally invasive ablative therapy for LAPC in select patients. Tumor necrosis is visible within 48 hours after treatment. Patient enrollment and data collection are ongoing. (Clinical trial registration number: NCT03033225.).
局部晚期胰腺癌(LAPC)常引起梗阻。与非治愈性手术相比,维替泊芬光动力疗法(PDT)可更安全地“减瘤”,并且比旧的 PDT 药物具有更多优势。我们旨在评估 EUS 引导下维替泊芬 PDT 消融不可切除的 LAPC 的可行性。
前瞻性纳入具有足够胆道引流的 LAPC 成人患者。排除标准为存在明显的转移性疾病负担、疾病累及十二指肠或主要动脉周长的>50%,以及最近有治愈意向的治疗。CT 于-28 至 0 天之间获得。在第 0 天,维替泊芬 0.4mg/kg 于 EUS 前 60-90 分钟输注,在此期间将扩散器放置在肿瘤中,并以 50J/cm 的光输送 333 秒。在第 2 天获得 CT,在第 1、2 和 14 天进行不良事件监测。主要结局是存在坏死。
8 例患者(62.5%为男性,平均年龄 65±7.9 岁)入组研究,5 例分期为 T3,2 例分期为 T2,1 例分期为 T1。大多数(n=4)原发性病变位于胰头部。术前平均肿瘤直径为 33.3±13.4mm。在第 2 天 CT 上,5 个病灶显示出直径为 15.7±5.5mm 的坏死区;3 例未发生坏死。在手术过程中和术后观察期(第 1-3 天)均未出现不良事件,患者报告的结局也没有变化。
在这项初步研究中,EUS 引导下维替泊芬 PDT 是可行的,并且作为一种微创消融治疗方法,在选择的患者中对 LAPC 具有一定的应用前景。治疗后 48 小时内可见肿瘤坏死。正在进行患者招募和数据收集。(临床试验注册号:NCT03033225.)。