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1. 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

Author

Korenblik, R., Olij, B., Aldrighetti, L. A., Abu Hilal, M., Ahle, Margareta, Arslan, B., van Baardewijk, L. J., Baclija, I, Bent, C., Bertrand, C. L., Björnsson, Bergthor, 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., Camacho, J. C., Cappelli, A., Carling, U., Chan, B. K. Y., Chang, D. H., Choi, J., Codina Font, J., 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., Dili, A., Erdmann, J. I, Fisher, O., Fondevila, C., Fretland, A., Garcia Borobia, F., Gelabert, A., Gerard, L., Giuliante, F., Gobardhan, P. D., Gomez, F., Grunberger, T., Grunhagen, 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., Lopez Ben, S., 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., Sampere Moragues, J., Sandström, Per A, Sarria, L., Schnitzbauer, A., Serenari, M., Serrablo, A., Smits, M. L. J., Sparrelid, E., Spuntrup, 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., Korenblik, R., Olij, B., Aldrighetti, L. A., Abu Hilal, M., Ahle, Margareta, Arslan, B., van Baardewijk, L. J., Baclija, I, Bent, C., Bertrand, C. L., Björnsson, Bergthor, 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., Camacho, J. C., Cappelli, A., Carling, U., Chan, B. K. Y., Chang, D. H., Choi, J., Codina Font, J., 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., Dili, A., Erdmann, J. I, Fisher, O., Fondevila, C., Fretland, A., Garcia Borobia, F., Gelabert, A., Gerard, L., Giuliante, F., Gobardhan, P. D., Gomez, F., Grunberger, T., Grunhagen, 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., Lopez Ben, S., 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., Sampere Moragues, J., Sandström, Per A, Sarria, L., Schnitzbauer, A., Serenari, M., Serrablo, A., Smits, M. L. J., Sparrelid, E., Spuntrup, 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., and van Dam, R. M.

Abstract

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

Published
2022
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2. Dragon 1 Protocol Manuscript

Author

R. Korenblik, B. Olij, L. A. Aldrighetti, M. Abu Hilal, M. Ahle, B. Arslan, L. J. van Baardewijk, I. Baclija, C. Bent, C. L. Bertrand, B. Björnsson, M. T. de Boer, S. W. de Boer, R. P. H. Bokkers, I. H. M. Borel Rinkes, S. Breitenstein, R. C. G. Bruijnen, P. Bruners, M. W. Büchler, J. C. Camacho, A. Cappelli, U. Carling, B. K. Y. Chan, D. H. Chang, J. choi, J. Codina Font, M. Crawford, D. Croagh, E. Cugat, R. Davis, D. W. De Boo, F. De Cobelli, J. F. De Wispelaere, O. M. van Delden, M. Delle, O. Detry, R. Díaz-Nieto, A. Dili, J. I. Erdmann, O. Fisher, C. Fondevila, Å. Fretland, F. Garcia Borobia, A. Gelabert, L. Gérard, F. Giuliante, P. D. Gobardhan, F. Gómez, T. Grünberger, D. J. Grünhagen, J. Guitart, J. Hagendoorn, J. Heil, D. Heise, E. Herrero, G. F. Hess, M. H. Hoffmann, R. Iezzi, F. Imani, J. Nguyen, E. Jovine, J. C. Kalff, G. Kazemier, T. P. Kingham, J. Kleeff, O. Kollmar, W. K. G. Leclercq, S. Lopez Ben, V. Lucidi, A. MacDonald, D. C. Madoff, S. Manekeller, G. Martel, A. Mehrabi, H. Mehrzad, M. R. Meijerink, K. Menon, P. Metrakos, C. Meyer, A. Moelker, S. Modi, N. Montanari, J. Navines, U. P. Neumann, P. Peddu, J. N. Primrose, X. Qu, D. Raptis, F. Ratti, F. Ridouani, C. Rogan, U. Ronellenfitsch, S. Ryan, C. Sallemi, J. Sampere Moragues, P. Sandström, L. Sarriá, A. Schnitzbauer, M. Serenari, A. Serrablo, M. L. J. Smits, E. Sparrelid, E. Spüntrup, G. A. Stavrou, R. P. Sutcliffe, I. Tancredi, J. C. Tasse, V. Udupa, D. Valenti, Y. Fundora, T. J. Vogl, X. Wang, S. A. White, W. A. Wohlgemuth, D. Yu, I. A. J. Zijlstra, C. A. Binkert, M. H. A. Bemelmans, C. van der Leij, E. Schadde, R. M. van Dam, UCL - SSS/IREC/IMAG - Pôle d'imagerie médicale, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service de chirurgie, UCL - (MGD) Service de radiologie - résonance magnétique, ​Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), RS: GROW - R2 - Basic and Translational Cancer Biology, Surgery, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: Carim - B06 Imaging, MUMC+: MA Heelkunde (9), CCA - Cancer Treatment and quality of life, Radiology and nuclear medicine, ACS - Pulmonary hypertension & thrombosis, Radiology & Nuclear Medicine, Radiology and Nuclear Medicine, ACS - Amsterdam Cardiovascular Sciences, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA -Cancer Center Amsterdam, CCA - Cancer Treatment and Quality of Life, ANS - Cellular & Molecular Mechanisms, ANS - Neuroinfection & -inflammation, ACS - Microcirculation, ANS - Neurovascular Disorders, ANS - Systems & Network Neuroscience, 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, and van Dam, R M

Subjects
Liver hypertrophy, Portal vein embolization (PVE), Hepatic Veins, Accreditation, MAJOR HEPATECTOMY, SDG 3 - Good Health and Well-being, Combined portal- and hepatic vein embolization (PVE, MULTIPLE, Hepatectomy, Humans, Multicenter Studies as Topic, Radiology, Nuclear Medicine and imaging, Cardiac and Cardiovascular Systems, Prospective Studies, HEPATOBILIARY SCINTIGRAPHY, Combined portal- and hepatic vein embolization (PVE/HVE), Kardiologi, Portal Vein, Liver Neoplasms, Colorectal cancer liver metastases (CRLM), Hepatic vein embolization (HVE), HVE), Future liver remnant (FLR), Hypertrophy, Embolization, Therapeutic, 2-STAGE HEPATECTOMY, VENOUS DEPRIVATION, Treatment Outcome, Liver, COMPLETE RESECTION, Cardiology and Cardiovascular Medicine, Hepatomegaly
Abstract

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).

Published
2022
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3. Preclinical assessment of a mathematical model for ablation zone prediction in thyroid laser ablation.

Author

Breschi L, Santos E, Camacho JC, Solomon SB, and Ridouani F

Subjects
Animals, Swine, Computer Simulation, Models, Theoretical, Reproducibility of Results, Laser Therapy methods, Laser Therapy instrumentation, Thyroid Gland surgery, Thyroid Gland pathology
Abstract

To develop and validate a 3D simulation model to calculate laser ablation (LA) zone size and estimate the volume of treated tissue for thyroid applications, a model was developed, taking into account dynamic optical and thermal properties of tissue change. For validation, ten Yorkshire swines were equally divided into two cohorts and underwent thyroid LA at 3 W/1,400 J and 3 W/1,800 J respectively with a 1064-nm multi-source laser (Echolaser X4 with Orblaze ™ technology; ElEn SpA, Calenzano, Italy). The dataset was analyzed employing key statistical measures such as mean and standard deviation (SD). Model simulation data were compared with animal gross histology. Experimental data for longitudinal length, width (transverse length), ablation volume and sphericity were 11.0 mm, 10.0 mm, 0.6 mL and 0.91, respectively at 1,400 J and 14.6 mm, 12.4 mm, 1.12 mL and 0.83, respectively at 1,800 J. Gross histology data showed excellent reproducibility of the ablation zone among same laser settings; for both 1,400 J and 1,800 J, the SD of the in vivo parameters was ≤ 0.7 mm, except for width at 1,800 J, for which the SD was 1.1 mm. Simulated data for longitudinal length, width, ablation volume and sphericity were 11.6 mm, 10.0 mm, 0.62 mL and 0.88, respectively at 1,400 J and 14.2 mm, 12.0 mm, 1.06 mL and 0.84, respectively at 1,800 J. Experimental data for ablation volume, sphericity coefficient, and longitudinal and transverse lengths of thermal damaged area showed good agreement with the simulation data. Simulation datasets were successfully incorporated into proprietary planning software (Echolaser Smart Interface, Elesta SpA, Calenzano, Italy) to provide guidance for LA of papillary thyroid microcarcinomas. Our mathematical model showed good predictability of coagulative necrosis when compared with data from in vivo animal experiments., (© 2024. The Author(s), under exclusive licence to Springer-Verlag London Ltd., part of Springer Nature.)

Published
2024
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