Abstract
Original language | English |
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Pages (from-to) | 805-813.e1 |
Journal | Journal of vascular and interventional radiology |
Volume | 33 |
Issue number | 7 |
Early online date | 2022 |
DOIs | |
Publication status | Published - Jul 2022 |
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In: Journal of vascular and interventional radiology, Vol. 33, No. 7, 07.2022, p. 805-813.e1.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Outcomes of Irreversible Electroporation for Perihilar Cholangiocarcinoma
T2 - A Prospective Pilot Study
AU - Franken, Lotte C.
AU - van Veldhuisen, Eran
AU - Ruarus, Alette H.
AU - Coelen, Robert J. S.
AU - Roos, Eva
AU - van Delden, Otto M.
AU - Besselink, Marc G.
AU - Klümpen, Heinz-Josef
AU - van Lienden, Krijn P.
AU - van Gulik, Thomas M.
AU - Meijerink, Martijn R.
AU - Erdmann, Joris I.
N1 - Funding Information: E.v.V. has received an honorarium from AngioDynamics; has received a research grant from AngioDynamics for the ANTILOPE study, investigating irreversible electroporation in pancreatic cancer; and has received support from AngioDynamics to attend a meeting. H.-J.K. is a subdomain leader of URACAN G5 biliary tract and the Dutch representative for the COST ACTION EURO-CHOLANGIO-NET project (HORIZON 2020) and has received travel support from EU grants. None of the other authors have identified a conflict of interest. K.P.v.L. receives consulting fees from AngioDynamics. M.R.M. receives consulting fees from AngioDynamics and Medtronic; has received an unrestricted grant from AngioDynamics for another project; receives book royalties from Springer; has received support for travel and meetings from AngioDynamics, Medtronic, Johnson & Johnson, and Guerbet; has received equipment and materials (needle electrodes for studies) from AngioDynamics and Cascination; and has received speaking fees from AngioDynamics, Medtronic, Johnson & Johnson, and Guerbet. The needles used for all IRE procedures were supplied by Angiodynamics. Funding Information: The study was partially supported by AngioDynamics BV . The needles used for all irreversible electroporation procedures were supplied by AngioDynamics. The authors would like to acknowledge Jantien A. Vogel, MD, PhD (Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, Cancer Center Amsterdam), Laurien G.P.H. Vroomen, MD, PhD (Department of Radiology and Nuclear Medicine, Amsterdam UMC location Vrije Universiteit, Cancer Center Amsterdam), Evelien A.C. Schouten, MSc (Department of Radiology and Nuclear Medicine, Amsterdam UMC location Vrije Universiteit, Cancer Center Amsterdam), Lynn Nooijen, MD (Department of Surgery, Amsterdam UMC location University of Amsterdam, Cancer Center Amsterdam), Olivier R. Busch, MD, PhD (Department of Surgery, Amsterdam UMC location University of Amsterdam, Cancer Center Amsterdam), Jeanin E. van Hooft, MD, PhD (Department of Gastroenterology and Hepatology, Amsterdam UMC location University of Amsterdam, Cancer Center Amsterdam), Geert Kazemier, MD, PhD (Department of Surgery, Amsterdam UMC location Vrije Universiteit, Cancer Center Amsterdam), Hester J. Scheffer, MD, PhD (Department of Radiology and Nuclear Medicine, Amsterdam UMC location Vrije Universiteit, Cancer Center Amsterdam), Jan de Vries, MD (Department of Radiology and Nuclear Medicine, Amsterdam UMC location Vrije Universiteit, Cancer Center Amsterdam), Barbara M. Zonderhuis, MD (Department of Surgery, Amsterdam UMC location Vrije Universiteit, Cancer Center Amsterdam), and Rutger-Jan Swijnenburg, MD, PhD (Department of Surgery, Amsterdam UMC location University of Amsterdam, Cancer Center Amsterdam). Funding Information: The study was partially supported by AngioDynamics BV. The needles used for all irreversible electroporation procedures were supplied by AngioDynamics. The authors would like to acknowledge Jantien A. Vogel, MD, PhD (Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, Cancer Center Amsterdam), Laurien G.P.H. Vroomen, MD, PhD (Department of Radiology and Nuclear Medicine, Amsterdam UMC location Vrije Universiteit, Cancer Center Amsterdam), Evelien A.C. Schouten, MSc (Department of Radiology and Nuclear Medicine, Amsterdam UMC location Vrije Universiteit, Cancer Center Amsterdam), Lynn Nooijen, MD (Department of Surgery, Amsterdam UMC location University of Amsterdam, Cancer Center Amsterdam), Olivier R. Busch, MD, PhD (Department of Surgery, Amsterdam UMC location University of Amsterdam, Cancer Center Amsterdam), Jeanin E. van Hooft, MD, PhD (Department of Gastroenterology and Hepatology, Amsterdam UMC location University of Amsterdam, Cancer Center Amsterdam), Geert Kazemier, MD, PhD (Department of Surgery, Amsterdam UMC location Vrije Universiteit, Cancer Center Amsterdam), Hester J. Scheffer, MD, PhD (Department of Radiology and Nuclear Medicine, Amsterdam UMC location Vrije Universiteit, Cancer Center Amsterdam), Jan de Vries, MD (Department of Radiology and Nuclear Medicine, Amsterdam UMC location Vrije Universiteit, Cancer Center Amsterdam), Barbara M. Zonderhuis, MD (Department of Surgery, Amsterdam UMC location Vrije Universiteit, Cancer Center Amsterdam), and Rutger-Jan Swijnenburg, MD, PhD (Department of Surgery, Amsterdam UMC location University of Amsterdam, Cancer Center Amsterdam). E.v.V. has received an honorarium from AngioDynamics; has received a research grant from AngioDynamics for the ANTILOPE study, investigating irreversible electroporation in pancreatic cancer; and has received support from AngioDynamics to attend a meeting. H.-J.K. is a subdomain leader of URACAN G5 biliary tract and the Dutch representative for the COST ACTION EURO-CHOLANGIO-NET project (HORIZON 2020) and has received travel support from EU grants. None of the other authors have identified a conflict of interest. K.P.v.L. receives consulting fees from AngioDynamics. M.R.M. received consulting fees from AngioDynamics and Medtronic; has received an unrestricted grant from AngioDynamics for another project; receives book royalties from Springer; has received support for travel and meetings from AngioDynamics, Medtronic, Johnson & Johnson, and Guerbet; has received equipment and materials (needle electrodes for studies) from AngioDynamics and Cascination; and has received speaking fees from AngioDynamics, Medtronic, Johnson & Johnson, and Guerbet. The needles used for all IRE procedures were supplied by Angiodynamics. Publisher Copyright: © 2022 SIR
PY - 2022/7
Y1 - 2022/7
N2 - Purpose: To investigate the safety and efficacy of percutaneous or open irreversible electroporation (IRE) in a prospective cohort of patients with locally advanced, unresectable perihilar cholangiocarcinoma (PHC). Materials and Methods: In a multicenter Phase I/II study, patients with unresectable PHC due to extensive vascular involvement or N2 lymph node metastases or local recurrence after resection for PHC were included and treated by open or percutaneous IRE combined with palliative chemotherapy (current standard of care). The primary outcome was the number of major adverse events occurring within 90 d after IRE (grade ≥3), and the upper limit was predefined at 60%. Secondary outcomes included technical success rate, hospital stay, and overall survival (OS). Results: Twelve patients (mean age, 63 y ± 12) were treated with IRE. The major adverse event rate was 50% (6 of 12 patients), and no 90-d mortality was observed. All procedures were technically successful, with no intraprocedural adverse events requiring additional interventions. The median OS from diagnosis was 21 mos (95% confidence interval, 15–27 mos), with a 1-y survival rate of 75% after IRE. Conclusions: Percutaneous IRE in selected patients with locally advanced PHC seems feasible, with a major adverse event rate of 50%, which was below the predefined upper safety limit in this prospective study. Future comparative research exploring the efficacy of IRE is warranted.
AB - Purpose: To investigate the safety and efficacy of percutaneous or open irreversible electroporation (IRE) in a prospective cohort of patients with locally advanced, unresectable perihilar cholangiocarcinoma (PHC). Materials and Methods: In a multicenter Phase I/II study, patients with unresectable PHC due to extensive vascular involvement or N2 lymph node metastases or local recurrence after resection for PHC were included and treated by open or percutaneous IRE combined with palliative chemotherapy (current standard of care). The primary outcome was the number of major adverse events occurring within 90 d after IRE (grade ≥3), and the upper limit was predefined at 60%. Secondary outcomes included technical success rate, hospital stay, and overall survival (OS). Results: Twelve patients (mean age, 63 y ± 12) were treated with IRE. The major adverse event rate was 50% (6 of 12 patients), and no 90-d mortality was observed. All procedures were technically successful, with no intraprocedural adverse events requiring additional interventions. The median OS from diagnosis was 21 mos (95% confidence interval, 15–27 mos), with a 1-y survival rate of 75% after IRE. Conclusions: Percutaneous IRE in selected patients with locally advanced PHC seems feasible, with a major adverse event rate of 50%, which was below the predefined upper safety limit in this prospective study. Future comparative research exploring the efficacy of IRE is warranted.
UR - http://www.scopus.com/inward/record.url?scp=85129949144&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.jvir.2022.03.024
DO - https://doi.org/10.1016/j.jvir.2022.03.024
M3 - Article
C2 - 35346858
SN - 1051-0443
VL - 33
SP - 805-813.e1
JO - Journal of vascular and interventional radiology
JF - Journal of vascular and interventional radiology
IS - 7
ER -