DRAGON Registry - International Multicenter Registry and Medical Image Bank for Patients With Primarily Unresectable Liver Cancer or Liver Metastases That Underwent Combined Portal and Hepatic Vein Embolization (PVE/HVE) to Increase Future Liver Remnant Before Resection.

Обзор

The DRAGON registry aims to collect data on combined portal and hepatic vein embolization (PVE/HVE) for liver tumors, a technique expected to enhance liver regeneration compared to standard PVE. This collaborative registry focuses on identifying associations between baseline clinical/imaging parameters, clinical outcomes, and safety for patients undergoing PVE/HVE.

Подробное описание

Retrospective and prospective

Первичные конечные точки

• Resectability three weeks after PVE/HVE and 5 years overall survival [Срок оценки: From enrolment until 5 year follow up]

Вторичные конечные точки (10)

• Number of complications during embolization [Срок оценки: Perioperative]
• Kinetic Growth Rate [%/week] [Срок оценки: 3 weeks after the embolization]
• Functional Growth Rate [%/week] [Срок оценки: Three weeks after the embolization]
• 90-day survival after embolization [Срок оценки: 90 days post-embolization / post-resection]
• Number of complications during surgery [Срок оценки: Perioperative]
• 90 day survival after resection [Срок оценки: 90 days]
• Clinical resection rates [Срок оценки: Until MDT decision on resection (yes/no), approximately 3-6 weeks after the embolization]
• Number of salvage procedures [Срок оценки: Approximately 3-6 weeks after the embolization]
• Number of participants with disease recurrence [Срок оценки: Until five years after the embolization/resection]
• Number of oncological interventions during follow up [Срок оценки: Until five years after the embolization/resection]

Критерии участия

Критерии включения

• Patients who have undergone PVE/HVE or technical variations on this procedure
• 18 Years and older
• Men and women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 5 центров

• MUMC+ — Maastricht
• Amsterdam UMC — Amsterdam
• Universitair Medisch Centrum Groningen — Groningen
• Leids Universitair Medisch Centrum — Leiden
• Erasmus MC — Rotterdam

Бельгия · 4 центра

• UZ Antwerpen — Edegem
• Erasmus Hospital — Anderlecht
• CHU de Liège — Liège
• UZ Gent — Ghent

США · 3 центра

• Rush University Medical Center — Chicago
• Mayo Clinic — Rochester
• Cleveland Clinic — Cleveland

Канада · 3 центра

• Juravinski Hospital and Cancer Centre — Hamilton
• The Ottawa Hospital — Ottawa
• McGill University Health Centre — Montreal

Германия · 3 центра

• University Hospital Aachen (Uniklinik RWTH Aachen) — Aachen
• Klinikum Saarbrücken — Saarbrücken
• Universitätsklinikum Halle — Halle

Великобритания · 3 центра

• Aintree University Hospital — Liverpool
• Newcastle upon Tyne Hospitals — Newcastle upon Tyne
• Queen Elizabeth Hospital — Birmingham

Австрия · 2 центра

• MedUni Wien — Vienna
• Social Center South (Klinik Favoriten) — Vienna

Испания · 2 центра

• Hospital Universitari Germans Trias i Pujol — Badalona
• Vall d'Hebron University Hospital — Barcelona

Швеция · 2 центра

• Karolinska University Hospital — Stockholm
• University Hospital Linköping — Linköping

Австралия · 1 центр

• Monash Medical Centre — Clayton

Новая Зеландия · 1 центр

• Auckland City Hospital — Grafton

Норвегия · 1 центр

• Oslo University Hospital — Oslo

Швейцария · 1 центр

• Klinik Hirslanden — Zurich

Публикации

• James S, van der Leij C, van Dam RM, Detry O. Liver venous deprivation before major hepatectomy-promising but still a work in progress. Hepatobiliary Surg Nutr. 2026 Feb 1;15(1):10. doi: 10.21037/hbsn-2025-560. Epub 2026 Jan 12. No abstract available. PMID 41676779
• James S, Smits J, van der Velden AL, Simon SR, Korenblik R, Dewulf MJL, van Dam RM, van der Leij C; DRAGON Trials Collaborative. Invited Commentary on "CIRSE Standards of Practice on Portal Vein Embolization and Double Vein Embolization/Liver Venous Deprivation". Cardiovasc Intervent Radiol. 2024 Sep;47(9):1311-1312. doi: 10.1007/s00270-024-03815-9. Epub 2024 Jul 29. No abstract available. PMID 39078494
• Korenblik R, Heil J, Smits J, James S, Olij B, Bechstein WO, Bemelmans MHA, Binkert CA, Breitenstein S, Williams M, Detry O, Dewulf MJL, Dili A, Grochola LF, Grote J, Heise D, Kalil JA, Metrakos P, Neumann UP, Pappas SG, Pennetta F, Schnitzbauer AA, Tasse JC, Winkens B, Olde Damink SWM, van der Leij C, Schadde E, van Dam RM; DRAGON trials collaborative. Liver regeneration after portal and hepatic PMID 38662462
• Korenblik R, van der Leij C, van Dam RM. Reply to: Portal and Hepatic Vein Embolization to Accelerate Future Liver Remnant Hypertrophy-The Road Towards Level One Evidence. Cardiovasc Intervent Radiol. 2023 Jan;46(1):166-167. doi: 10.1007/s00270-022-03271-3. Epub 2022 Sep 20. No abstract available. PMID 36127520
• Korenblik R, van Zon JFJA, Olij B, Heil J, Dewulf MJL, Neumann UP, Olde Damink SWM, Binkert CA, Schadde E, van der Leij C, van Dam RM; DRAGON Trials Collaborative. Resectability of bilobar liver tumours after simultaneous portal and hepatic vein embolization versus portal vein embolization alone: meta-analysis. BJS Open. 2022 Nov 2;6(6):zrac141. doi: 10.1093/bjsopen/zrac141. PMID 36437731
• 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 PMID 35790566
• Chang X, Korenblik R, Olij B, Knapen RRMM, van der Leij C, Heise D, den Dulk M, Neumann UP, Schaap FG, van Dam RM, Olde Damink SWM. Influence of cholestasis on portal vein embolization-induced hypertrophy of the future liver remnant. Langenbecks Arch Surg. 2023 Jan 21;408(1):54. doi: 10.1007/s00423-023-02784-w. PMID 36680689
• Heil J, Korenblik R, Heid F, Bechstein WO, Bemelmans M, Binkert C, Bjornsson B, Breitenstein S, Detry O, Dili A, Dondelinger RF, Gerard L, Gimenez-Maurel T, Guiu B, Heise D, Hertl M, Kalil JA, Klein JJ, Lakoma A, Neumann UP, Olij B, Pappas SG, Sandstrom P, Schnitzbauer A, Serrablo A, Tasse J, Van der Leij C, Metrakos P, Van Dam R, Schadde E. Preoperative portal vein or portal and hepatic vein embo PMID 33661306

Идентификаторы

NCT: NCT07717437 · 2021-2578

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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