一种新型自组装粘膜下注射肽溶液用于内镜下结肠直肠病变粘膜切除术的可行性:一项多中心研究

IF 1.5 Q4 GASTROENTEROLOGY & HEPATOLOGY DEN open Pub Date : 2025-02-13 DOI:10.1002/deo2.70069
Keigo Sato, Takehide Fukuchi, Shinpei Kondo, Yuya Nakano, Yoko Hachisu, Kengo Kasuga, Ayako Matsui, Hironori Aoki, Kohei Takizawa, Shiko Kuribayashi, Yoji Takeuchi, Toshio Uraoka
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引用次数: 0

摘要

虽然一种新型的粘膜下注射材料由一种完全合成的、自组装肽溶液PuraLift组成,最近已经在日本上市,但关于这种溶液的实用性有一些报道。本研究的目的是探讨purallift在常规内镜下粘膜切除术(EMR)临床应用的可行性。方法于2023年1月至2023年5月在5所医院的内镜科室进行多中心回顾性研究。连续使用PuraLift进行EMR治疗5 - 20毫米结直肠病变的患者被纳入每个研究所该解决方案的介绍。主要终点是“有效切除”率,定义为病理完全切除,“有效注射”定义为由于EMR期间黏膜提升的适当维持,不需要超过一次额外注射。结果使用PuraLift对70例患者的110个病灶进行了常规EMR治疗。109例(99%)病灶行整体切除,102例(93%)病灶行完全切除。超过95%的病变为肿瘤。只有两个病灶需要额外注射。均为单次追加注射,总注射量中位数为1.5 mL,因此有效注射率为93%(95%可信区间为86% ~ 96%)。研究期间未发生不良事件。结论虽然需要与其他材料进行直接比较,但PuraLift作为EMR的注射材料是可行的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Feasibility of a novel self-assembling submucosal injection peptide solution for endoscopic mucosal resection of colorectal lesions: A multicenter study

Objectives

Although a novel submucosal injection material consisting of a fully synthetic, self-assembling peptide solution, PuraLift, has recently become commercially available in Japan, there are a few reports regarding the usefulness of this solution. The aim of this study was to investigate the feasibility of PuraLift for conventional endoscopic mucosal resection (EMR) in clinical practice.

Methods

This multicenter retrospective study was conducted at the endoscopy units of five institutions from January 2023 to May 2023. Consecutive patients who underwent EMR with PuraLift for 5–20-mm colorectal lesions were included in the introduction of this solution at each institute. The primary endpoint was the “effective resection” rate, defined as pathological complete resection, with “effective injection” defined as requiring no more than one additional injection due to adequate maintenance of mucosal lifting during EMR.

Results

In total, 110 lesions in 70 patients were treated by conventional EMR using PuraLift. En-bloc resection was performed for 109 (99%) lesions, and complete resection was performed for 102 (93%) lesions. More than 95% of the lesions were neoplastic. Additional injections were required in only two lesions. Both were single additional injections, and the median overall injection volume was 1.5 mL. Therefore, the effective injection rate was 93% (95% confidence interval, 86%–96%). No adverse events occurred during the study period.

Conclusions

Although direct comparison with other materials is required, PuraLift seems feasible as an injection material for EMR.

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