非结直肠肝转移患者行肝切除术:non - colmet研究组。

IF 1.2 3区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY
Marcello Di Martino, Giorgio Ercolani, Federica Cipriani, Gianluca Baiocchi, Roberto Bordonaro, Matteo Cescon, Antonio Frena, Felice Giuliante, Gianluca Grazi, Salvatore Gruttadauria, Giovanni Marchegiani, Riccardo Memeo, Fabrizio Panaro, Fabrizio Romano, Andrea Ruzzenente, Marcello Spampinato, Guido Alberto Tiberio, Guido Torzilli, Roberto Troisi, Matteo Donadon
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引用次数: 0

摘要

背景:虽然结肠直肠肝转移瘤(CRLM)切除术是一种成熟的手术,其生存率优于单纯化疗,但非结肠直肠肝转移瘤(NCRLM)的肝切除术仍存在争议。这些患者包括一个多样化和异质的群体,通常被排除在手术之外。到目前为止,关于NCRLM手术治疗的回顾性报道很少。NONCOLMET研究旨在建立一个全面的NCRLM肝切除术患者注册表,提供可靠的回顾性和前瞻性数据来描述临床实践、结果和确定预后因素。方法:该研究包括两个阶段:(1)回顾性收集2010-2024年期间接受治疗的患者数据;(2)从2025年开始前瞻性招募。年龄≥18岁,经组织学证实行肝切除术的NCRLM患者将被纳入研究。数据将通过RedCap平台上的标准化电子病例报告表格(eCRF)进行记录。将评估以下终点:肿瘤预后,包括总生存期(OS)、无病生存期(DFS)和疾病复发;术后30天和90天的死亡率,包括死因;术后并发症;短期和长期结果的预测变量。这些结果将用于制定风险评分模型。该研究方案已在clinaltrials .gov注册(NCT06542926)。结论:NONCOLMET将为NCRLM的手术治疗提供重要的见解,帮助完善患者选择标准,并为未来的临床指南提供信息。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Non-colorectal liver metastases undergoing liver resection: the NONCOLMET study group.

Background: While the resection of colorectal liver metastases (CRLM) is a well-established procedure, with survival rates superior to chemotherapy alone, controversial data still exist on liver resection for non-colorectal liver metastases (NCRLM). These patients comprise a diverse and heterogeneous group usually excluded from surgery. To date, only few retrospective reports are available on the surgical treatment of NCRLM. The NONCOLMET study aims to build a comprehensive registry of patients undergoing liver resection for NCRLM, providing robust retrospective and prospective data to describe clinical practices, outcomes, and identify prognostic factors.

Methods: The study consists of two phases: (1) retrospective collection of data from patients treated between 2010-2024 and (2) prospective enrolment from 2025. Patients aged ≥18 years with histologically confirmed NCRLM undergoing liver resection will be included. Data will be recorded via a standardized electronic case report form (eCRF) in the RedCap platform. The following endpoints will be evaluated: oncological outcomes including overall survival (OS), disease-free Survival (DFS) and disease relapse; post-operative mortality at 30 and 90 days with causes of death; post-procedural complications; predictor variables of short- and long-term outcomes. These outcomes will be used to elaborate a risk score models. The study protococol was registered on Clincaltrials.gov (NCT06542926).

Conclusions: NONCOLMET will offer crucial insights into the surgical management of NCRLM, helping refine patient selection criteria and informing future clinical guidelines.

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来源期刊
Digestive Surgery
Digestive Surgery 医学-外科
CiteScore
4.90
自引率
3.70%
发文量
25
审稿时长
3 months
期刊介绍: ''Digestive Surgery'' presents a comprehensive overview in the field of gastrointestinal surgery. Interdisciplinary in scope, the journal keeps the specialist aware of advances in all fields that contribute to improvements in the diagnosis and treatment of gastrointestinal disease. Particular emphasis is given to articles that evaluate not only recent clinical developments, especially clinical trials and technical innovations such as new endoscopic and laparoscopic procedures, but also relevant translational research. Each contribution is carefully aligned with the need of the digestive surgeon. Thus, the journal is an important component of the continuing medical education of surgeons who want their practice to benefit from a familiarity with new knowledge in all its dimensions.
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