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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04272931




Registration number
NCT04272931
Ethics application status
Date submitted
7/01/2020
Date registered
17/02/2020
Date last updated
3/02/2023

Titles & IDs
Public title
DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE
Scientific title
DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization to Accelerate Future Liver Remnant (FLR) Hypertrophy
Secondary ID [1] 0 0
NL71535.068.19
Universal Trial Number (UTN)
Trial acronym
DRAGON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer Liver Metastases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Portal and Hepatic Vein Embolization

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.


Treatment: Surgery: 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)
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ability of each center to enroll 3 patients in 12 months without mortality due to the intervention.
Timepoint [1] 0 0
1 year/ 90 day mortality
Secondary outcome [1] 0 0
Efficacy assessment: standardized future liver remnant volume
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Feasibility assessment: resection rate
Timepoint [2] 0 0
1 year follow up
Secondary outcome [3] 0 0
Mortality assessment
Timepoint [3] 0 0
90 days
Secondary outcome [4] 0 0
Overall survival after PVE/HVE
Timepoint [4] 0 0
1 year follow up
Secondary outcome [5] 0 0
Oncological effectiveness of PVE/HVE
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
General complication assessment
Timepoint [6] 0 0
90 days
Secondary outcome [7] 0 0
Liver specific complication assessment
Timepoint [7] 0 0
90 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Monash Health, Clayton - Clayton
Recruitment postcode(s) [1] 0 0
NSW 2050 - Camperdown
Recruitment postcode(s) [2] 0 0
VIC 3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Namen
Country [7] 0 0
Belgium
State/province [7] 0 0
Liège
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Montréal
Country [10] 0 0
Germany
State/province [10] 0 0
Saarland
Country [11] 0 0
Germany
State/province [11] 0 0
Saksen-Anhalt
Country [12] 0 0
Germany
State/province [12] 0 0
Frankfurt
Country [13] 0 0
Italy
State/province [13] 0 0
Bologna
Country [14] 0 0
Italy
State/province [14] 0 0
Brescia
Country [15] 0 0
Italy
State/province [15] 0 0
Milan
Country [16] 0 0
Italy
State/province [16] 0 0
Roma
Country [17] 0 0
Netherlands
State/province [17] 0 0
Limburg
Country [18] 0 0
Netherlands
State/province [18] 0 0
Noord-Holland
Country [19] 0 0
Netherlands
State/province [19] 0 0
Zuid-Holland
Country [20] 0 0
Netherlands
State/province [20] 0 0
Amsterdam
Country [21] 0 0
Netherlands
State/province [21] 0 0
Breda
Country [22] 0 0
Netherlands
State/province [22] 0 0
Eindhoven
Country [23] 0 0
Netherlands
State/province [23] 0 0
Groningen
Country [24] 0 0
Netherlands
State/province [24] 0 0
Utrecht
Country [25] 0 0
Norway
State/province [25] 0 0
Oslo
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Gerona
Country [28] 0 0
Spain
State/province [28] 0 0
Zaragoza
Country [29] 0 0
Sweden
State/province [29] 0 0
Linköping
Country [30] 0 0
Sweden
State/province [30] 0 0
Stockholm
Country [31] 0 0
Switzerland
State/province [31] 0 0
Basel-Stadt
Country [32] 0 0
Switzerland
State/province [32] 0 0
Winterthur
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Hampshire
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Merseyside
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Belfast
Country [36] 0 0
United Kingdom
State/province [36] 0 0
London
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Other
Name
Maastricht University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Koningin Wilhelmina Fonds
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT04272931
Trial related presentations / publications
Korenblik R, Olij B, Aldrighetti LA, Hilal MA, Ahle M, Arslan B, van Baardewijk LJ, Baclija I, Bent C, Bertrand CL, Bjornsson B, de Boer MT, de Boer SW, Bokkers RPH, Rinkes IHMB, Breitenstein S, Bruijnen RCG, Bruners P, Buchler MW, Camacho JC, Cappelli A, Carling U, Chan BKY, Chang DH, Choi J, Font JC, Crawford M, Croagh D, Cugat E, Davis R, De Boo DW, De Cobelli F, De Wispelaere JF, van Delden OM, Delle M, Detry O, Diaz-Nieto R, Dili A, Erdmann JI, Fisher O, Fondevila C, Fretland A, Borobia FG, Gelabert A, Gerard L, Giuliante F, Gobardhan PD, Gomez F, Grunberger T, Grunhagen DJ, Guitart J, Hagendoorn J, Heil J, Heise D, Herrero E, Hess GF, Hoffmann MH, Iezzi R, Imani F, Nguyen J, Jovine E, Kalff JC, Kazemier G, Kingham TP, Kleeff J, Kollmar O, Leclercq WKG, Ben SL, Lucidi V, MacDonald A, Madoff DC, Manekeller S, Martel G, Mehrabi A, Mehrzad H, Meijerink MR, Menon K, Metrakos P, Meyer C, Moelker A, Modi S, Montanari N, Navines J, Neumann UP, Peddu P, Primrose JN, Qu X, Raptis D, Ratti F, Ridouani F, Rogan C, Ronellenfitsch U, Ryan S, Sallemi C, Moragues JS, Sandstrom P, Sarria L, Schnitzbauer A, Serenari M, Serrablo A, Smits MLJ, Sparrelid E, Spuntrup E, Stavrou GA, Sutcliffe RP, Tancredi I, Tasse JC, Udupa V, Valenti D, Fundora Y, Vogl TJ, Wang X, White SA, Wohlgemuth WA, Yu D, Zijlstra IAJ, Binkert CA, Bemelmans MHA, van der Leij C, Schadde E, van Dam RM. Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1391-1398. doi: 10.1007/s00270-022-03176-1. Epub 2022 Jul 5.
Public notes

Contacts
Principal investigator
Name 0 0
Ronald M van Dam, MD PhD
Address 0 0
Maastricht University Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04272931