Kanzaki Hiromitsu, Horii Joichiro, Takenaka Ryuta, Nakagawa Hiroyuki, Matsueda Kazuhiro, Tsuzuki Takao, Kita Masahide, Yamasaki Yasushi, Tanaka Takehiro, Iwamuro Masaya, Kawano Seiji, Kawahara Yoshiro, Tomoda Jun, Okada Hiroyuki
Department of Gastroenterology, Okayama University Hospital, Okayama, Japan.
Department of Gastroenterology, Fukuyama Medical Center, Hiroshima, Japan.
Endosc Int Open. 2022 Jun 10;10(6):E712-E718. doi: 10.1055/a-1793-9439. eCollection 2022 Jun.
Because the endoscopic treatment for non-ampullary duodenal adenoma (NADA) has a non-negligible risk of adverse events (AEs), a safe and easy treatment for NADA is desirable. This was a multicenter prospective trial evaluating the efficacy and safety of cold forceps polypectomy (CFP) for diminutive NADAs. This study was prospectively conducted at six general hospitals and one university hospital. The inclusion criteria were histologic and endoscopic diagnosis of low-grade NADA measuring ≤ 6 mm. A second endoscopy was scheduled for 1 month after CFP. After confirmation of the success of CFP, 6-month and 12-month surveillance endoscopies were scheduled. The primary endpoint was the endoscopic and histologic disease disappearance rates at the 12-month endoscopy. Thirty-nine lesions from 38 patients were prospectively included. Median tumor size at enrollment was 5 mm (range 3-6 mm). There were four cases of remnant lesions at the second endoscopy, and the lesion disappearance rate of single CFP was 89.7 % (35 /39; 95 % confidence interval (CI), 76.9 %-97.9 %). In three cases, complete removal of the lesion was achieved with a single re-CFP, but one case required four repeat CFPs. The lesion disappearance rate at 12-month endoscopy was 97.4 % (38 /39; 95 %CI, 86.8 %-99.5 %). During the follow-up period, no AEs related to CFP were observed. CFP for NADA ≤ 6 mm was safe and effective in this study. This common endoscopic method to remove lesions may be an option for treatment of diminutive NADAs.
由于非壶腹十二指肠腺瘤（NADA）的内镜治疗存在不可忽视的不良事件（AE）风险，因此需要一种安全简便的NADA治疗方法。这是一项多中心前瞻性试验，评估冷活检钳息肉切除术（CFP）治疗微小NADA的疗效和安全性。本研究在六家综合医院和一家大学医院前瞻性开展。纳入标准为组织学和内镜诊断为低级别NADA且直径≤6mm。CFP术后1个月安排第二次内镜检查。确认CFP成功后，安排6个月和12个月的监测性内镜检查。主要终点是12个月内镜检查时的内镜和组织学疾病消失率。前瞻性纳入了38例患者的39个病变。入组时肿瘤大小的中位数为5mm（范围3 - 6mm）。第二次内镜检查时有4例残留病变，单次CFP的病变消失率为89.7%（35/39；95%置信区间（CI），76.9% - 97.9%）。3例患者通过单次再次CFP实现了病变的完全切除，但1例患者需要4次重复CFP。12个月内镜检查时的病变消失率为97.4%（38/39；95%CI，86.8% - 99.5%）。在随访期间，未观察到与CFP相关的AE。本研究中，CFP治疗≤6mm的NADA安全有效。这种常见的内镜下病变切除方法可能是治疗微小NADA的一种选择。
