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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
Maastricht Univ, Netherlands; Maastricht Univ Med Ctr, Netherlands.
Maastricht Univ, Netherlands; Maastricht Univ Med Ctr, Netherlands.
Osped San Raffaele, Italy.
Fdn Poliambulanza, Italy.
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2022 (English)In: Cardiovascular and Interventional Radiology, ISSN 0174-1551, E-ISSN 1432-086X, Vol. 45, p. 1391-1398Article in journal (Refereed) Published
Abstract [en]

Study Purpose The DRAGON 1 trial aims to assess training, implementation, safety and feasibility of combined portal- and hepatic-vein embolization (PVE/HVE) to accelerate future liver remnant (FLR) hypertrophy in patients with borderline resectable colorectal cancer liver metastases. Methods The DRAGON 1 trial is a worldwide multicenter prospective single arm trial. The primary endpoint is a composite of the safety of PVE/HVE, 90-day mortality, and one year accrual monitoring of each participating center. Secondary endpoints include: feasibility of resection, the used PVE and HVE techniques, FLR-hypertrophy, liver function (subset of centers), overall survival, and disease-free survival. All complications after the PVE/HVE procedure are documented. Liver volumes will be measured at week 1 and if applicable at week 3 and 6 after PVE/HVE and follow-up visits will be held at 1, 3, 6, and 12 months after the resection. Results Not applicable. Conclusion DRAGON 1 is a prospective trial to assess the safety and feasibility of PVE/HVE. Participating study centers will be trained, and procedures standardized using Work Instructions (WI) to prepare for the DRAGON 2 randomized controlled trial. Outcomes should reveal the accrual potential of centers, safety profile of combined PVE/HVE and the effect of FLR-hypertrophy induction by PVE/HVE in patients with CRLM and a small FLR.

Place, publisher, year, edition, pages
Springer , 2022. Vol. 45, p. 1391-1398
Keywords [en]
Colorectal cancer liver metastases (CRLM); Portal vein embolization (PVE); Hepatic vein embolization (HVE); Combined portal- and hepatic vein embolization (PVE; HVE); Liver hypertrophy; Future liver remnant (FLR)
National Category
Cardiology and Cardiovascular Disease
Identifiers
URN: urn:nbn:se:liu:diva-187431DOI: 10.1007/s00270-022-03176-1ISI: 000821975300001PubMedID: 35790566OAI: oai:DiVA.org:liu-187431DiVA, id: diva2:1689539
Note

Funding Agencies|Dutch Cancer Society (KWF); Abbott Laboratories; Maastricht University; Maastricht University Medical Center; NIHR; Guerbet

Available from: 2022-08-23 Created: 2022-08-23 Last updated: 2025-02-10Bibliographically approved

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Ahle, MargaretaBjörnsson, BergthorSandström, Per A

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Department of Radiology in LinköpingDivision of Surgery, Orthopedics and OncologyFaculty of Medicine and Health SciencesDepartment of Surgery in Linköping
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Cardiovascular and Interventional Radiology
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