AI Article Synopsis

  • The DRAGON 1 trial investigates the training, implementation, safety, and feasibility of a combined portal- and hepatic-vein embolization (PVE/HVE) approach to encourage liver growth in patients with borderline resectable colorectal cancer liver metastases.
  • The study is a worldwide multicenter, single-arm trial, with primary endpoints focusing on the safety of the procedure and 90-day mortality, while secondary endpoints look at resection feasibility, liver function, and overall survival rates.
  • The findings aim to standardize procedures for future trials and enhance understanding of the safety and effects of PVE/HVE on liver growth in this patient population.

Article Abstract

Study Purpose: The DRAGON 1 trial aims to assess training, implementation, safety and feasibility of combined portal- and hepatic-vein embolization (PVE/HVE) to accelerate future liver remnant (FLR) hypertrophy in patients with borderline resectable colorectal cancer liver metastases.

Methods: The DRAGON 1 trial is a worldwide multicenter prospective single arm trial. The primary endpoint is a composite of the safety of PVE/HVE, 90-day mortality, and one year accrual monitoring of each participating center. Secondary endpoints include: feasibility of resection, the used PVE and HVE techniques, FLR-hypertrophy, liver function (subset of centers), overall survival, and disease-free survival. All complications after the PVE/HVE procedure are documented. Liver volumes will be measured at week 1 and if applicable at week 3 and 6 after PVE/HVE and follow-up visits will be held at 1, 3, 6, and 12 months after the resection.

Results: Not applicable.

Conclusion: DRAGON 1 is a prospective trial to assess the safety and feasibility of PVE/HVE. Participating study centers will be trained, and procedures standardized using Work Instructions (WI) to prepare for the DRAGON 2 randomized controlled trial. Outcomes should reveal the accrual potential of centers, safety profile of combined PVE/HVE and the effect of FLR-hypertrophy induction by PVE/HVE in patients with CRLM and a small FLR.

Trial Registration: Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019).

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9458562PMC
http://dx.doi.org/10.1007/s00270-022-03176-1DOI Listing

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