门肝静脉联合栓塞治疗结直肠肝转移患者的安全性和有效性（DRAGON1）：一项多中心、单臂临床试验

IF 13.6 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Europe Pub Date : 2025-04-10 DOI:10.1016/j.lanepe.2025.101284

Remon Korenblik , Sinéad James , Jens Smits , Rafael Díaz-Nieto , Rob Davis , Benjamin K.Y. Chan , Joris I. Erdmann , IJsbrand A.J. Zijlstra , Pieter J.W. Arntz , Otto Kollmar , Martin H. Hoffmann , David G. Vass , Richard Lindsay , Matteo Serenari , Alberto Cappelli , Paul D. Gobardhan , Farshad Imani , Yiliam Fundora Suarez , Fernando Gómez Muños , Dirk J. Grünhagen , R. Young

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引用次数: 0

摘要

背景：为了完全清除结直肠肝转移瘤（CRLM），通常需要进行大肝脏切除术。未来残肝（FLR）体积/功能不足的患者在肝切除术后肝功能衰竭（PHLF）的风险很高，需要进行诱导残肝肥大的手术以确保安全切除。这些手术的最新变种是门静脉和肝静脉联合栓塞（PVE/HVE）。DRAGON 1试验评估PVE/HVE的安全性和有效性，同时评估DRAGON 2随机试验的招募潜力。dragon 1是一项前瞻性、单臂、国际、多中心试验。包括因FLR小而无法切除的前期CRLM患者。主要结果是中心招募三名患者并进行PVE/HVE和肝脏切除术的能力，无90天死亡率。次要结果包括招募能力、PVE/HVE技术细节、FLR容积变化、并发症和切除率。该研究已在ClinicalTrials.gov注册，标识符：NCT04272931。共纳入来自43个中心的102例患者。24个中心（24/43 = 56%）招募了3名或更多患者，20个中心（20/43 = 47%）在没有90天死亡率的情况下实现了这一目标。在96例接受PVE/HVE治疗的患者中，栓塞后无死亡发生，尽管有2例患者报告了主要并发症。86例患者（86/96 = 90%）完成切除，7例患者（7/86 = 8%）在90天内死亡。19例（19/86 = 22%）患者出现PHLF B/C级（国际肝脏外科研究组标准）。dragon 1表明PVE/HVE是安全的，在前期不可切除的CRLM中无栓塞相关死亡率，低发病率和高切除率。资助荷兰癌症协会、英国国家健康和护理研究所、马斯特里赫特UMC+、雅培实验室和Guerbet。

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Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial

Background

Major liver resection is often required for complete clearance of colorectal liver metastases (CRLM). Patients with insufficient future liver remnant (FLR) volume/function are at high risk of post-hepatectomy liver failure (PHLF) and require FLR hypertrophy-inducing procedures to enable safe resection. The most recent variant of these procedures is combined portal and hepatic vein embolization (PVE/HVE). The DRAGON 1 trial evaluates the safety and efficacy of PVE/HVE, while assessing recruitment potential for the DRAGON 2 randomized trial.

Methods

DRAGON 1 is a prospective, single-arm, international, multicenter trial. Patients with upfront unresectable CRLM due to a small FLR were included. The primary outcome was the ability of centers to recruit three patients and perform PVE/HVE and liver resection without 90-day mortality. Secondary outcomes included recruitment capacity, PVE/HVE technical details, FLR volume changes, complications, and resection rates. The study is registered at ClinicalTrials.gov, identifier: NCT04272931.

Findings

In total, 102 patients were included from 43 centers. Twenty-four centers (24/43 = 56%) recruited three or more patients, and 20 centers (20/43 = 47%) achieved this without 90-day mortality. Of 96 patients undergoing PVE/HVE, no post-embolization mortality occurred, though major complications were reported in two patients. Resection was completed in 86 patients (86/96 = 90%), with seven patients (7/86 = 8%) dying within 90 days. PHLF grade B/C (International Study Group of Liver Surgery criteria) occurred in 19 patients (19/86 = 22%).

Interpretation

DRAGON 1 demonstrates that PVE/HVE is safe, with no embolization-related mortality, low morbidity, and high resection rates in upfront unresectable CRLM.

Funding

The Dutch Cancer Society, National Institute for Health and Care Research UK, Maastricht UMC+, Abbott Laboratories and Guerbet.

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来源期刊

Lancet Regional Health-Europe Multiple-

CiteScore

19.90

自引率

1.40%

发文量

260

审稿时长

9 weeks

期刊介绍： The Lancet Regional Health – Europe, a gold open access journal, is part of The Lancet's global effort to promote healthcare quality and accessibility worldwide. It focuses on advancing clinical practice and health policy in the European region to enhance health outcomes. The journal publishes high-quality original research advocating changes in clinical practice and health policy. It also includes reviews, commentaries, and opinion pieces on regional health topics, such as infection and disease prevention, healthy aging, and reducing health disparities.