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

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

Abstract

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.