Matsumoto Kazuyuki, Kato Hironari, Itoi Takao, Kitano Masayuki, Hara Kazuo, Kuwatani Masaki, Takenaka Mamoru, Ashida Reiko, Mukai Shuntaro, Okuno Nozomi, Kawakubo Kazumichi, Yamazaki Tatsuhiro, Sakurai Jun, Nakatsuka Yuki, Yoshida Michihiro, Otsuka Motoyuki
Gastroenterology and Hepatology, Okayama University Hospital, Okayama, Japan.
Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.
Endoscopy. 2025 Apr;57(4):321-329. doi: 10.1055/a-2452-4607. Epub 2024 Oct 25.
Endoscopic ultrasonography (EUS)-guided ethanol injection (EI) has recently been introduced as one of the management strategies for pancreatic neuroendocrine neoplasms (PNENs); however, its role as a surgical alternative is unclear. We evaluated the efficacy and safety of EUS-EI in treating small PNENs through a prospective multicenter study.Patients with grade 1 tumors of ≤15 mm confirmed by pathology were included. The primary end point assessed efficacy and safety, measuring complete ablation using computed tomography at 1 and 6 months, prevention of adverse events (AEs) within 1 month, severe pancreatic fistula at 1 month, and incidence/worsening of diabetes mellitus (DM) at 6 months. The composite end point of EUS-EI was compared with that of historical results of a study based on surgical treatment.25 patients with PNENs, with a median tumor size of 10.1 mm, were treated using EUS-EI. The composite primary end point was achieved by 76.0% of patients (19/25; 95%CI 54.9%-90.6%), a proportion significantly higher than that of surgical treatment ( = 0.008). Regarding efficacy, 88.0% (22/25) of patients achieved complete ablation at 1 and 6 months (95%CI 68.8%-97.5%). Regarding safety, 96.0% (24/25) of patients had no severe AEs within 1 month (95%CI 79.7%-99.9%). No patients had severe pancreatic fistulas at 1 month, and 84.0% (21/25) had no incidence or exacerbation, or both, of DM at 6 months (95%CI 63.9%-95.5%).EUS-EI is safe and could be a potent treatment option for patients with small PNENs.
内镜超声引导下乙醇注射（EUS-EI）最近已被引入作为胰腺神经内分泌肿瘤（PNENs）的治疗策略之一；然而，其作为手术替代方案的作用尚不清楚。我们通过一项前瞻性多中心研究评估了EUS-EI治疗小PNENs的疗效和安全性。纳入经病理证实为1级且肿瘤直径≤15mm的患者。主要终点评估疗效和安全性，在1个月和6个月时使用计算机断层扫描测量完全消融情况，1个月内预防不良事件（AE），1个月时预防严重胰瘘，以及6个月时糖尿病（DM）的发生率/恶化情况。将EUS-EI的复合终点与基于手术治疗的一项研究的历史结果进行比较。25例PNENs患者接受了EUS-EI治疗，肿瘤中位大小为10.1mm。76.0%的患者（19/25；95%CI 54.9%-90.6%）达到了复合主要终点，这一比例显著高于手术治疗组（P = 0.008）。在疗效方面，88.0%（22/25）的患者在1个月和6个月时实现了完全消融（95%CI 68.8%-97.5%）。在安全性方面，96.0%（24/25）的患者在1个月内无严重AE（95%CI 79.7%-99.9%）。1个月时无患者发生严重胰瘘，84.0%（21/25）的患者在6个月时无DM发生或病情加重（95%CI 63.9%-95.5%）。EUS-EI是安全的，对于小PNENs患者可能是一种有效的治疗选择。
