Matsumoto Kazuyuki, Uchida Daisuke, Takeuchi Yasuto, Kato Hironari, Fujii Yuki, Harada Kei, Hattori Nao, Sato Ryosuke, Obata Taisuke, Matsumi Akihiro, Miyamoto Kazuya, Horiguchi Shigeru, Tsutsumi Koichiro, Yasui Kazuya, Harada Ryo, Fujii Masakuni, Otsuka Motoyuki
Department of Gastroenterology and Hepatology Okayama University Hospital Okayama Japan.
Department of Gastroenterological Surgery, Transplant and Surgical Oncology Okayama University Hospital Okayama Japan.
DEN Open. 2025 Jan 29;5(1):e70073. doi: 10.1002/deo2.70073. eCollection 2025 Apr.
Endoscopic ultrasonography (EUS)-guided radiofrequency ablation has recently been introduced as one of the management strategies for small pancreatic neuroendocrine neoplasms (PNENs). However, prospective data on its safety and efficacy remain limited.
This prospective pilot study was conducted at Okayama University Hospital from May 2023 to December 2024. Patients with grade 1 PNENs ≤15 mm, confirmed by EUS-guided fine-needle aspiration, were included. The primary endpoint was safety (adverse events [AEs] evaluated according to the 2010 guidelines of the American Society for Gastrointestinal Endoscopy. Severe AEs were defined as moderate or higher in American Society for Gastrointestinal Endoscopy grading and grade ≥3. Secondary endpoints included efficacy (complete response on contrast-enhanced computed tomography at 1 and 6 months), treatment details, device failure, diabetes mellitus exacerbation, and overall survival at 6 months.
Five patients with non-functional PNENs (median age: 64 years; median tumor size: 10 mm) were treated. AEs occurred in two patients (40%, 2/5), although none was severe. Both patients developed asymptomatic pseudocysts, one experienced mild pancreatitis, and both resolved with conservative treatment. The complete response rates on contrast-enhanced computed tomography at one and 6 months were 100%. The median procedure time was 16 min without any device failure, and the median hospitalization was 5 days. None of the patients developed new-onset or worsening diabetes mellitus. The 6-month overall survival rate was 100%.
EUS-guided radiofrequency ablation demonstrated a high complete response rate with no severe AEs in this pilot study, suggesting a minimally invasive option for small, low-grade PNENs (jRCTs062230014).
内镜超声（EUS）引导下射频消融术最近已被引入作为小胰腺神经内分泌肿瘤（PNENs）的治疗策略之一。然而，关于其安全性和有效性的前瞻性数据仍然有限。
这项前瞻性试点研究于2023年5月至2024年12月在冈山大学医院进行。纳入经EUS引导下细针穿刺确诊为1级PNENs且直径≤15 mm的患者。主要终点是安全性（根据美国胃肠内镜学会2010年指南评估不良事件[AEs]。严重不良事件定义为美国胃肠内镜学会分级中为中度或更高且等级≥3。次要终点包括有效性（1个月和6个月时对比增强计算机断层扫描的完全缓解）、治疗细节、设备故障、糖尿病加重以及6个月时的总生存率。
治疗了5例无功能性PNENs患者（中位年龄：64岁；中位肿瘤大小：10 mm）。2例患者（40%，2/5）发生了不良事件，不过均不严重。两名患者均出现无症状假性囊肿，1例经历了轻度胰腺炎，两者均通过保守治疗得到缓解。1个月和6个月时对比增强计算机断层扫描的完全缓解率均为100%。中位手术时间为16分钟，无任何设备故障，中位住院时间为5天。所有患者均未出现新发或恶化的糖尿病。6个月总生存率为100%。
在这项试点研究中，EUS引导下射频消融术显示出高完全缓解率且无严重不良事件，提示其是小的、低级别PNENs的一种微创选择（jRCTs062230014）。
