Ligresti Dario, Binda Cecilia, Fugazza Alessandro, Maida Marcello, Traina Mario, Anderloni Andrea, Fabbri Carlo, Tarantino Ilaria
Digestive Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT, Palermo, Italy.
Unit of Gastroenterology and Digestive Endoscopy, Morgagni-Pierantoni Hospital, Forli, Italy.
Endosc Int Open. 2024 Aug 23;12(8):E962-E967. doi: 10.1055/a-2376-1913. eCollection 2024 Aug.
Direct endoscopic necrosectomy (DEN) represents the first-line treatment for walled-off necrosis (WON). However, DEN has a non-negligible rate of overall adverse events (AE) and is time-consuming due to the lack of dedicated devices. This pilot study was designed to evaluate the feasibility and safety of a novel dedicated device for DEN named Necrolit. In this multicenter retrospective analysis,16 patients with WON who underwent DEN using Necrolit were compared with a control group treated with non-dedicated devices. Technical success, AEs, clinical success, number of procedures per patient, procedure time, and length of hospital stay were evaluated. Necrolit technical performance indicators were also studied. Technical success was obtained in all patients in both groups. In the Necrolit group, the overall AE rate was 10.1% vs. 15.9% in the control group. Clinical success was 100% in the Necrolit group vs. 81.3% in the control group. Patients treated with Necrolit underwent a slightly lower mean number of procedures (4.1 ± 2.3 vs. 5.1 ± 1.9) with comparable mean procedure time (67.8 ± 39 minutes vs. 70.1 ± 32.6 minutes). Mean duration of hospital stay was 39.4 days (± 30.9) in the Necrolit group vs. 43 days (± 29.4) in the control group. Device-related technical performance was rated positively. DEN with Necrolit appears feasible and safe.
直接内镜坏死组织切除术（DEN）是包裹性坏死（WON）的一线治疗方法。然而，DEN的总体不良事件（AE）发生率不可忽视，且由于缺乏专用设备，手术耗时较长。本前瞻性研究旨在评估一种名为Necrolit的新型DEN专用设备的可行性和安全性。在这项多中心回顾性分析中，将16例使用Necrolit进行DEN的WON患者与使用非专用设备治疗的对照组进行比较。评估了技术成功率、不良事件、临床成功率、每位患者的手术次数、手术时间和住院时间。还研究了Necrolit的技术性能指标。两组所有患者均获得技术成功。Necrolit组的总体AE发生率为10.1%，而对照组为15.9%。Necrolit组的临床成功率为100%，而对照组为81.3%。接受Necrolit治疗的患者平均手术次数略少（4.1±2.3次对5.1±1.9次），平均手术时间相当（67.8±39分钟对70.1±32.6分钟）。Necrolit组的平均住院时间为39.4天（±30.9天），而对照组为43天（±29.4天）。与设备相关的技术性能得到了积极评价。使用Necrolit进行DEN似乎是可行和安全的。
