Your session is about to expire
← Back to Search
Procedure
PVE vs PVE/HVE Procedures for Liver Cancer (DRAGON Trial)
N/A
Waitlist Available
Led By Erik Schadde, MD FACS FEBS
Research Sponsored by Maastricht University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
DRAGON Trial Summary
This trial will compare two procedures for liver cancer: portal vein embolization (PVE) and portal vein embolization/hepatic vein embolization (PVE/HVE). PVE/HVE is a newer procedure that is faster and more extensive in liver size and function growth. This trial will compare the two procedures in terms of safety and feasibility.
Who is the study for?
This trial is for adults with colorectal cancer that has spread to the liver, who may benefit from a new procedure aimed at enhancing liver regeneration before surgery. Candidates must not be bedridden more than half the time, have no untreatable extrahepatic disease except possibly resectable lung metastases, and understand and consent to the trial.Check my eligibility
What is being tested?
DRAGON 1 evaluates a novel technique combining portal and hepatic vein embolization (PVE/HVE) intended to stimulate faster and more significant growth of liver size and function compared to standard PVE alone. This pretrial assesses safety before moving on to a randomized controlled comparison in DRAGON 2.See study design
What are the potential side effects?
While specific side effects are not listed here, procedures like PVE/HVE can potentially cause pain at the injection site, bleeding, infection, or unintended impact on liver function which will be closely monitored during this safety evaluation.
DRAGON Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability of each center to enroll 3 patients in 12 months without mortality due to the intervention.
Secondary outcome measures
Efficacy assessment: standardized future liver remnant volume
Feasibility assessment: resection rate
General complication assessment
+4 moreDRAGON Trial Design
1Treatment groups
Experimental Treatment
Group I: Portal and Hepatic Vein EmbolizationExperimental Treatment1 Intervention
3 patients per center over one year approximately 90 patients in total. Patients will undergo portal vein and hepatic vein embolization instead of only portal vein embolization.
Find a Location
Who is running the clinical trial?
Maastricht UniversityLead Sponsor
232 Previous Clinical Trials
13,180,267 Total Patients Enrolled
Koningin Wilhelmina FondsOTHER
6 Previous Clinical Trials
2,440 Total Patients Enrolled
Erik Schadde, MD FACS FEBSPrincipal InvestigatorKantonsspital Winterthur/ Rush University Medical Center, Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a type of liver cancer called Perihilar Cholangiocarcinoma (PHCC).A special type of scan called a CT chest is used to check if the cancer has spread to other parts of the body. If the cancer has spread too much and cannot be removed, or if it has spread only a little but can potentially be cured in the future, you may or may not be able to participate in the study.You have cancer that has spread to places other than your lungs.
Research Study Groups:
This trial has the following groups:- Group 1: Portal and Hepatic Vein Embolization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger