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DRAGON 1 - training, accreditation, implementation and safety evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to accelerate Future Liver Rem-nant (FLR) hypertrophy

DRAGON 1 - training, accreditation, implementation and safety evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to accelerate Future Liver Rem-nant (FLR) hypertrophy - DRAGON 1 trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54956
Enrollment
30
Registered
2020-03-26
Start date
2020-05-08
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Colorectal cancer liver metastases (CRLM) 2.

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria • Patients with primarily unresectable/potentially resectable CRLM after conversion chemotherapy with a FLR

Exclusion criteria

Exclusion criteria: Exclusion criteria • Patients with extrahepatic disease other than lung metastases • Patients with metastatic disease to the lung that cannot be ablated or resected will be excluded • Patients with intrahepatic Cholangiocarcinoma (IHCC) • Patients with Perihilar Cholangiocarcinoma (PHCC) • Patients with Hepatocellular Carcinoma (HCC) • Pregnant or lactating women will be excluded. Women in conceiving age are required to take contraceptives or have to provide documentation of other means of contraception to be enrolled. • Progression by modified RECIST criteria on cross-sectional imaging after conversion chemotherapy is an exclusion criterion. • Complete response in cross-sectional imaging after conversion chemotherapy, which is certainly a rare event

Design outcomes

Primary

MeasureTime frame
• Demonstrate ability of center to enroll 3 patients in 12 months safely

Secondary

MeasureTime frame
• Efficacy assessment of hypertrophy induced • Assessment of variety of techniques - LVD vs. Double vein embolization vs. staged PVE/HVE • Feasibility assessment (proceeding to resection) • Safety of PVE/HVE (mortality/ morbidity) • Oncological effectiveness of PVE/HVE (recurrence/progression

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 27, 2026