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DOI 10.1007/s00270-022-03176-1

Медицинская библиотека · Cardiovascular and interventional radiology · 2022

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.

Korenblik R, Olij B, Aldrighetti L A, Hilal M Abu, Ahle M, Arslan B, van Baardewijk L J, Baclija I, Bent C, Bertrand C L, Björnsson B, de Boer M T, de Boer S W, Bokkers R P H, Rinkes I H M Borel, Breitenstein S, Bruijnen R C G, Bruners P, Büchler M W, Camacho J C, Cappelli A, Carling U, Chan B K Y, Chang D H, Choi J, Font J Codina, Crawford M, Croagh D, Cugat E, Davis R, De Boo D W, De Cobelli F, De Wispelaere J F, van Delden O M, Delle M, Detry O, Díaz-Nieto R, Dili A, Erdmann J I, Fisher O, Fondevila C, Fretland Å, Borobia F Garcia, Gelabert A, Gérard L, Giuliante F, Gobardhan P D, Gómez F, Grünberger T, Grünhagen D J, Guitart J, Hagendoorn J, Heil J, Heise D, Herrero E, Hess G F, Hoffmann M H, Iezzi R, Imani F, Nguyen J, Jovine E, Kalff J C, Kazemier G, Kingham T P, Kleeff J, Kollmar O, Leclercq W K G, Ben S Lopez, Lucidi V, MacDonald A, Madoff D C, Manekeller S, Martel G, Mehrabi A, Mehrzad H, Meijerink M R, Menon K, Metrakos P, Meyer C, Moelker A, Modi S, Montanari N, Navines J, Neumann U P, Peddu P, Primrose J N, Qu X, Raptis D, Ratti F, Ridouani F, Rogan C, Ronellenfitsch U, Ryan S, Sallemi C, Moragues J Sampere, Sandström P, Sarriá L, Schnitzbauer A, Serenari M, Serrablo A, Smits M L J, Sparrelid E, Spüntrup E, Stavrou G A, Sutcliffe R P, Tancredi I, Tasse J C, Udupa V, Valenti D, Fundora Y, Vogl T J, Wang X, White S A, Wohlgemuth W A, Yu D, Zijlstra I A J, Binkert C A, Bemelmans M H A, van der Leij C, Schadde E, van Dam R M

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Аннотация

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.

TRIAL REGISTRATION: Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019).

Для цитирования: Korenblik R, Olij B, Aldrighetti L A, Hilal M Abu, Ahle M, Arslan B, van Baardewijk L J, Baclija I, Bent C, Bertrand C L, Björnsson B, de Boer M T, de Boer S W, Bokkers R P H, Rinkes I H M Borel, Breitenstein S, Bruijnen R C G, Bruners P, Büchler M W, Camacho J C, Cappelli A, Carling U, Chan B K Y, Chang D H, Choi J, Font J Codina, Crawford M, Croagh D, Cugat E, Davis R, De Boo D W, De Cobelli F, De Wispelaere J F, van Delden O M, Delle M, Detry O, Díaz-Nieto R, Dili A, Erdmann J I, Fisher O, Fondevila C, Fretland Å, Borobia F Garcia, Gelabert A, Gérard L, Giuliante F, Gobardhan P D, Gómez F, Grünberger T, Grünhagen D J, Guitart J, Hagendoorn J, Heil J, Heise D, Herrero E, Hess G F, Hoffmann M H, Iezzi R, Imani F, Nguyen J, Jovine E, Kalff J C, Kazemier G, Kingham T P, Kleeff J, Kollmar O, Leclercq W K G, Ben S Lopez, Lucidi V, MacDonald A, Madoff D C, Manekeller S, Martel G, Mehrabi A, Mehrzad H, Meijerink M R, Menon K, Metrakos P, Meyer C, Moelker A, Modi S, Montanari N, Navines J, Neumann U P, Peddu P, Primrose J N, Qu X, Raptis D, Ratti F, Ridouani F, Rogan C, Ronellenfitsch U, Ryan S, Sallemi C, Moragues J Sampere, Sandström P, Sarriá L, Schnitzbauer A, Serenari M, Serrablo A, Smits M L J, Sparrelid E, Spüntrup E, Stavrou G A, Sutcliffe R P, Tancredi I, Tasse J C, Udupa V, Valenti D, Fundora Y, Vogl T J, Wang X, White S A, Wohlgemuth W A, Yu D, Zijlstra I A J, Binkert C A, Bemelmans M H A, van der Leij C, Schadde E, van Dam R M. 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.. Cardiovascular and interventional radiology. 2022. DOI: 10.1007/s00270-022-03176-1.

Предметные рубрики MeSH

AccreditationEmbolization, TherapeuticHepatectomyHepatic VeinsHepatomegalyHumansHypertrophyLiverLiver NeoplasmsMulticenter Studies as TopicPortal VeinProspective StudiesTreatment Outcome
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