Results of the prospective international multicenter DRAGON 1 trial investigating combined portal and hepatic vein embolization in patients with colorectal liver metastases and small future liver remnants

Introduction Patients with extensive colorectal liver metastases (CRLM) often require Future Liver Remnant (FLR) hypertrophy-inducing procedures to minimize the risk of developing post-hepatectomy liver failure. Combined Portal and Hepatic Vein Embolization (PVE/HVE) may accelerate FLR hypertrophy and lead to higher resection rates. The aim of the DRAGON 1 trial is to assess the training, implementation, feasibility, safety, and efficacy of PVE/HVE in patients with primarily unresectable CRLM.

Methods The DRAGON 1 is a prospective, single-arm, international, multicenter trial. The primary endpoint is the ability of each center to recruit 3 patients within 12 months, without 90-day mortality due to complications related to the PVE/HVE procedure. Secondary endpoints include resection rate, FLR-hypertrophy, complications, 90-day mortality post-resection, recurrence and 1-year survival

Results A total of 102 patients from 43 centers across 14 countries were enrolled between May 2020 and October 2022. 24 of the 43 centers were able to enroll 3 patients. No procedure-related mortality was reported. There was one serious adverse event related to the intervention. PVE/HVE resulted in a high kinetic growth rate and 90% of the patients were resected.

Conclusions The DRAGON 1 trial demonstrates that PVE/HVE is safe and 56% of the participating centers were able to recruit 3 patients. Additionally, a high kinetic growth rate resulted in a resection rate of 90% after PVE/HVE.

 

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Publication History

Article published online:
23 January 2024