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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., 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.

Published
2022
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2. 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

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, Korenblik, R, Olij, B, Aldrighetti, L A, Hilal, M Abu, Ahle, M, Arslan, B, van Baardewijk, L J, Baclija, I, Bent, C, Claude, Bertrand, 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, Jean-François, van Delden, O M, Delle, M, Detry, O, Díaz-Nieto, R, Dili, Alexandra, 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, 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, Korenblik, R, Olij, B, Aldrighetti, L A, Hilal, M Abu, Ahle, M, Arslan, B, van Baardewijk, L J, Baclija, I, Bent, C, Claude, Bertrand, 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, Jean-François, van Delden, O M, Delle, M, Detry, O, Díaz-Nieto, R, Dili, Alexandra, 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

Abstract

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. 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. Not applicable. 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. Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019).

Published
2022

3. 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., 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, 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., 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, 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.

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

4. 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

Zorgeenheid Orthopaedie Medisch, MS Radiologie, MS CGO, Regenerative Medicine and Stem Cells, Cancer, Other research (not in main researchprogram), Experimentele Afdeling Longziekten, 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, Zorgeenheid Orthopaedie Medisch, MS Radiologie, MS CGO, Regenerative Medicine and Stem Cells, Cancer, Other research (not in main researchprogram), Experimentele Afdeling Longziekten, 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

Published
2022

9. 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

10. Laparoscopic resection of clinically suspected gastric stromal tumors.

Author

Berindoague R, Targarona EM, Feliu X, Artigas V, Balagué C, Aldeano A, Lahoud A, Navines J, Fernandez-Sallent E, and Trias M

Subjects
Adult, Aged, Aged, 80 and over, Anastomosis, Roux-en-Y, Female, Gastrectomy adverse effects, Gastrointestinal Stromal Tumors pathology, Humans, Length of Stay, Male, Middle Aged, Retrospective Studies, Stomach Neoplasms pathology, Treatment Outcome, Gastrectomy methods, Gastrointestinal Stromal Tumors surgery, Laparoscopy adverse effects, Stomach Neoplasms surgery
Abstract

Gastrointestinal stromal tumors (GISTs) account for 5% of all gastric tumors. Preoperative diagnosis is relatively difficult because biopsy samples are rarely obtained during fibergastroscopy. Surgical radical resection is the gold standard treatment, allowing pathologic study for both diagnosis and prognosis. Laparoscopic resection has become an alternative to the open approach, but long-term results are not well known. The aim of this study is to report experience with laparoscopic resection, placing special emphasis on preoperative diagnosis and describing long-term results. A retrospective analysis was made of all patients undergoing a laparoscopic resection for clinically suspected gastrointestinal stromal tumors between November 1998 and August 2006 at 2 tertiary hospitals. The medical records of all participants were reviewed regarding surgical technique, clinicopathologic features, and postoperative long-term outcome. Laparoscopic gastric resection was attempted in 22 patients (13 women and 9 men) with a mean age of 66.7 years (range, 29-84 years). One patient had 2 gastric tumors. Tumor localization was upper gastric third in 6 patients, mid-gastric third in 7, and distal third in 10. Surgical techniques were transgastric submucosal excision (n = 1), wedge resection (n = 13), partial gastrectomy with Y-en-Roux reconstruction (n = 6), and total gastrectomy with Y-en-Roux reconstruction (n = 2). Two patients (9.1%) required conversion to the open procedure because of tumor size. Postoperative morbidity was delayed gastric emptying in 3 patients. Median postoperative stay was 6 days (range, 4-32 days). Pathologic and immunohistochemical study confirmed gastrointestinal stromal tumors in 18 cases. The other 4 cases were adenomyoma, hamartoma, plasmocytoma, and parasitic tumor (anisakis). Median tumor size was 5.6 cm (range, 2.5-12.5 cm) in cases of gastrointestinal stromal tumors. Malignant risk of gastrointestinal stromal tumors assessed according to mitotic index and size was low (n = 8), intermediate (n = 6), or high (n = 4). After a median follow-up of 32 months (range, 1-72 months), there was 1 case of recurrence of GIST. Definitive preoperative diagnosis of gastric submucosal tumors is frequently difficult. The laparoscopic approach to surgical treatment of these tumors seems safe and is associated with acceptable intermediate-term results, especially in cases of gastrointestinal stromal tumors.

Published
2006
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