DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE (DRAGON)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04272931 |
Recruitment Status :
Recruiting
First Posted : February 17, 2020
Last Update Posted : July 12, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer Liver Metastases | Procedure: Portal and Hepatic Vein Embolization | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 125 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Multicenter, international, prospective, multi-center trial to test enrolment capacity of participants and safety of Portal and Hepatic Vein Embolization (PVE/HVE): DRAGON 1 will form the basis of a planned subsequent trial ("DRAGON 2") that will compare PVE with PVE/HVE. In DRAGON 1 every center has to demonstrate the ability to enroll 3 patients in 12 months safely |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization to Accelerate Future Liver Remnant (FLR) Hypertrophy |
Actual Study Start Date : | May 8, 2020 |
Estimated Primary Completion Date : | October 1, 2022 |
Estimated Study Completion Date : | October 1, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Portal and Hepatic Vein Embolization
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.
|
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)
Other Names:
|
- Ability of each center to enroll 3 patients in 12 months without mortality due to the intervention. [ Time Frame: 1 year/ 90 day mortality ]Ability of each center to enroll 3 patients for PVE/HVE in 12 months safely and perform the procedure including the liver resection without 90-day mortality after resection due to complications. If this goal is achieved center will be enrolled in DRAGON 2.
- Efficacy assessment: standardized future liver remnant volume [ Time Frame: 6 weeks ]Increased of standardized future liver remnant volume between initial imaging and imaging at 1 week, 3 weeks, 6 weeks, degree of hypertrophy based on standard future liver remnant volume, kinetic growth
- Feasibility assessment: resection rate [ Time Frame: 1 year follow up ]ion of patients proceeding to complete resection (=resection rate)
- Mortality assessment [ Time Frame: 90 days ]90-mortality after resection
- Overall survival after PVE/HVE [ Time Frame: 1 year follow up ]Overall survival
- Oncological effectiveness of PVE/HVE [ Time Frame: 1 year ]Disease-free survival after 1 year
- General complication assessment [ Time Frame: 90 days ]90-day complications, general (Clavien-Dindo)
- Liver specific complication assessment [ Time Frame: 90 days ]90-day complications, liver specific (FABIB-classification)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with primarily unresectable/potentially resectable CRLM after conversion chemotherapy with a FLR <30% in normal livers, or 40% in livers chemotherapy damaged livers.
- 18 years and older
- Patients up to ECOG 3 (not more than 50% bedbound)
- Patients with non-resected primary colorectal cancer (CRC) may be included if and only if there is an intent to remove the CRC after the liver treatment (liver first approach)
- Staging CT chest and (if symptomatic) CT/MRI excludes unresectable extrahepatic disease, while metastatic disease that may be cured in the future, is included.
- Patients with resectable lung metastases or lung metastases that and be ablated can be included only after statement about resectability/ablatability by tumor board
- Patients have to be to understand the trial and provide informed consent.
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 not be eligible
- Potential to get pregnant has to be excluded (obligatory contraception etc.)
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04272931
Contact: Remon Korenblik, MD | +31 637297507 | remon.korenblik@mumc.nl | |
Contact: Ronald M. van Dam, MD, PhD | r.van.dam@mumc.nl |

Principal Investigator: | Ronald M van Dam, MD PhD | Maastricht University Medical Center | |
Principal Investigator: | Erik Schadde, MD FACS FEBS | Kantonsspital Winterthur/ Rush University Medical Center, Chicago | |
Principal Investigator: | Marc AH Bemelmans, MD PhD | Maastricht University Medical Center | |
Principal Investigator: | Christiaan van der Leij, MD PhD | Maastricht University Medical Center | |
Principal Investigator: | Christoph A Binkert, Prof.Dr.Med | Cantonal Hospital Winterthur |
Responsible Party: | Maastricht University |
ClinicalTrials.gov Identifier: | NCT04272931 |
Other Study ID Numbers: |
NL71535.068.19 |
First Posted: | February 17, 2020 Key Record Dates |
Last Update Posted: | July 12, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Future Liver Remnant Portal and Hepatic Vein Embolization Colorectal Liver Metastases |
Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes |