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DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE

NCT04272931 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2023-02-03

No results posted yet for this study

Summary

Brief Summary: Some colorectal liver metastases can only be resected after inducing liver regeneration by portal vein embolization (PVE) to increase size function of the future liver remnant (FLR). While PVE is standard, embolization of portal vein and hepatic veins (PVE/HVE) on one side of the liver may faster and more extensive liver size and function growth. PVE/HVE is a novel procedure and requires a safety and feasibility evaluation in a pretrial (DRAGON1) to then be compared in a randomized controlled trial (RCT) to PVE (DRAGON 2).

Conditions

  • Colorectal Cancer Liver Metastases

Interventions

PROCEDURE

Portal and Hepatic Vein Embolization

Procedure/Surgery: Combined portal vein embolization and hepatic vein embolization (PVE/HVE) • All techniques of PVE allowed (ipsi-lateral, contra-lateral, trans-splenic, all embolization agents except for ethanol alone) • All modifications of HVE allowed (venous occlusion umbrellas; trans-jugular, trans-hepatic, no use of vein glue to avoid lung embolization; staged approach allowed, but first PVE, then HVE and within 48 hours)

Sponsors & Collaborators

  • Koningin Wilhelmina Fonds

    collaborator OTHER

  • Maastricht University

    lead OTHER

Principal Investigators

  • Ronald M van Dam, MD PhD · Maastricht University Medical Center

  • Erik Schadde, MD FACS FEBS · Kantonsspital Winterthur/ Rush University Medical Center, Chicago

  • Marc AH Bemelmans, MD PhD · Maastricht University Medical Center

  • Christiaan van der Leij, MD PhD · Maastricht University Medical Center

  • Christoph A Binkert, Prof.Dr.Med · Cantonal Hospital Winterthur

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-08
Primary Completion
2022-10-01
Completion
2023-12-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04272931 on ClinicalTrials.gov