The DRAGON 2 Trial

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Maastricht University
Study ID
NCT05428735
Status
Recruiting
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Conditions

  • Colorectal Cancer Liver Metastases (CRLM)
  • Small Future Liver Remnant (FLR)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Embolization — PROCEDURE
    Portal Vein embolization with Glue by a transhepatic approach vs. PVE and Hepatic Vein Occlusion with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure

Study Details

In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).

Key Dates

Start date
Apr 1, 2022
Status verified
Sep 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2029

Study Design

Enrollment
348 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Portal Vein Embolization (PVE) alone - (control arm)
    Portal Vein Embolization (PVE) alone
  • Experimental: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
    Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)

Primary Outcome Measure

Volume sufficient for resection at week 3 after the embolization [ Time Frame: 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06510
Kevin Billingsley
David Madoff

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Yale New Haven Hospital· New Haven, CT

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