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

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ClinicalTrials.gov Identifier: NCT04272931
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : November 9, 2020
Sponsor:
Collaborator:
Koningin Wilhelmina Fonds
Information provided by (Responsible Party):
Maastricht University

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Liver Metastases Procedure: Portal and Hepatic Vein Embolization Not Applicable

Detailed Description:
Detailed Description: Resection of liver metastases from colorectal cancer (CRLM) improves survival compared to chemotherapy alone and may lead to cure in up to 40% of patients. Surgical resectability is limited by location of metastases and by FLR size and function. Commonly, the volume of the future liver remnant (FLR) should be at least 30% of the functional FLR volume. If this volume criterion is not met, the induction of liver regeneration between a two-stage hepatectomy is performed at many centers, with the aim to render patients resectable and reduce the risk of post hepatectomy liver failure. Gold standard to induce regeneration is the embolization of the portal vein branches to the tumor carrying liver (PVE) to induce regeneration of the FLR. Recently, combined embolization of both portal and hepatic veins (PVE/HVE) has been described as an alternative to portal vein embolization because it accelerates and increases growth of the FLR. PVE/HVE combines simultaneous embolization of the portal main branches into the tumor bearing liver and the hepatic vein draining them. The tissue in the part of the liver treated with PVE/HVE stays viable because the hepatic artery continues to supplies the liver deprived of portal and hepatic veins. Preclinical studies in pigs have demonstrated feasibility of this method and human case series show accelerated and increased liver growth. No multi-center evaluation has been performed so far. DRAGON 1 is an 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 the RCT DRAGON 2 to compare PVE with PVE/HV. DRAGON 2 is expected to start in 2021.
Study Design
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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 : May 7, 2021
Estimated Study Completion Date : May 7, 2022
Arms and Interventions
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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:
  • Liver venous deprivation (LVD)
  • Double embolization


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Feasibility assessment: resection rate [ Time Frame: 1 year follow up ]
    ion of patients proceeding to complete resection (=resection rate)

  3. Mortality assessment [ Time Frame: 90 days ]
    90-mortality after resection

  4. Overall survival after PVE/HVE [ Time Frame: 1 year follow up ]
    Overall survival

  5. Oncological effectiveness of PVE/HVE [ Time Frame: 1 year ]
    Disease-free survival after 1 year

  6. General complication assessment [ Time Frame: 90 days ]
    90-day complications, general (Clavien-Dindo)

  7. Liver specific complication assessment [ Time Frame: 90 days ]
    90-day complications, liver specific (FABIB-classification)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Remon Korenblik, MD +31 637297507 remon.korenblik@mumc.nl
Contact: Ronald M. van Dam, MD, PhD r.van.dam@mumc.nl

Locations
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Sponsors and Collaborators
Maastricht University
Koningin Wilhelmina Fonds
Investigators
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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
More Information
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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: November 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University:
Future Liver Remnant
Portal and Hepatic Vein Embolization
Colorectal Liver Metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes