The Dragon PLC Trial (DRAGON-PLC)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Maastricht University
Study ID
NCT06914648
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

The goal of the DRAGON PLC clinical trial is to determine whether portal vein embolization (PVE) combined with hepatic vein embolization (HVE) improves resectability and overall survival in patients with initially unresectable primary liver cancer compared to standard PVE alone. This trial specifically focuses on patients with hepatocellular carcinoma and cholangiocarcinoma. The main questions this trial aims to answer are whether combined PVE and HVE increases the proportion of patients who become resectable within 3 weeks and improves 5-year overall survival compared to PVE alone by enhancing liver hypertrophy. Participants will: * Undergo either standard PVE or combined PVE and HVE. * Have regular imaging to assess liver resectability. * Be monitored for survival outcomes up to 5 years after intervention.

Key Dates

Start date
Apr 1, 2025
Status verified
Feb 2025
Primary completion
Nov 15, 2032
Completion
Nov 15, 2032

Study Design

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

Arms

  • Active Comparator: Portal Vein Embolization (PVE) - 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)

Primary Outcome Measure

Resectability 3 weeks after embolisation [ Time Frame: 3 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Yale School of Medicine HospitalNew HavenConnecticut06510
K. Billingsley, Prof. (PRINCIPAL_INVESTIGATOR)
D.C. Madoff, Prof. (PRINCIPAL_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
M. Dixon, Dr. (PRINCIPAL_INVESTIGATOR)
B. Arslan, Dr. (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
P. Starlinger, Dr. (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
T.P. Kingham, Prof. (PRINCIPAL_INVESTIGATOR)
F. Riduani, Dr. (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
D. Kwon, Prof. (PRINCIPAL_INVESTIGATOR)
S. Gadani, Prof. (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Yale School of Medicine Hospital· New Haven, CTRush University Medical Center· Chicago, ILMayo Clinic· Rochester, MNMemorial Sloan Kettering Cancer Center· New York, NYCleveland Clinic· Cleveland, OH

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