Marquardt, Steffen
Kirstein, Martha M.
Brüning, Roland
Zeile, Martin
Ferrucci, Pier Francesco
Prevoo, Warner
Radeleff, Boris
Trillaud, Hervé
Tselikas, Lambros
Vicente, Emilio
Wiggermann, Philipp
Manns, Michael P.
Vogel, Arndt
Wacker, Frank K.
Article History
Received: 2 February 2018
Revised: 2 August 2018
Accepted: 27 August 2018
First Online: 25 September 2018
Compliance with ethical standards
:
: The scientific guarantor of this publication is Frank K. Wacker.
: Steffen Marquardt reports a travel grant and lecture fees from Delcath Systems, Inc. during the conduct of the study.Martha M. Kirstein has no conflicts of interest related to the subject matter of the article.She received honoraria and travel grants from Shire, Novartis, Ipsen and Roche outside the submitted work.Roland Brüning has no conflicts of interest related to the subject matter of the article or outside the submitted work.Martin Zeile reports consulting and proctoring fees from Delcath systems, Inc.He reports consulting fees for Boston Scientific, Inc. outside the submitted work.Pier Francesco Ferrucci has no conflicts of interest related to the subject matter of the article or outside the submitted work.Warner Prevoo reports proctoring fees from Delcath systems, Inc.Boris Radeleff has no conflicts of interest related to the subject matter of the article or outside the submitted work.Hervé Trillaud has no conflicts of interest related to the subject matter of the article or outside the submitted work.Lambros Tselikas has no conflicts of interest related to the subject matter of the article.He reports proctoring/speaking fees for Cook Medical, BTG, GE Healthcare, Sirtex Medical, AMGEN and Pfizer.Emilio Vicente has no conflicts of interest related to the subject matter of the article or outside the submitted work.Philipp Wiggermann takes part in "FOCUS Trial in Hepatic Dominant Ocular Melanoma - A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma".He has no conflicts of interest outside the submitted work.Michael P. Manns has no conflicts of interest related to the subject matter of the article or outside the submitted work.Arndt Vogel reports personal fees and travel grants from Delcath Systems, Inc. He reports personal fees from Roche, Bayer, Lilly, Incyte, BMS, MSD and Amgen outside the submitted work.Frank K. Wacker reports a grant and personal/proctoring fees from Delcath Systems, Inc. during the conduct of the study. He reports grants from Siemens Healthineers, Promedicus Ltd., BMBF, Forschungscampus STIMULATE, DFG, Rebirth-Cluster of Excellence and personal fees from Novartis Pharma GmbH outside the submitted work.After data collection of the current study, Hannover Medical School participated in the Phase 2 Clinical Trials in Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC) (NCT 02415036).
: No complex statistical methods were necessary for this paper.
: Written informed consent was obtained from all subjects (patients) in this study.
: Institutional Review Board approval was obtained.
: Only three of the patients were included in a retrospective single-centre study: "Safety and efficacy of chemosaturation in patients with primary and secondary liver tumors", published in <i>Journal of Research and Clinical Oncology</i>, including 29 patients with different primary and secondary liver malignancies.In our current study only patients with intrahepatic cholangiocarcinoma across nine different hospitals in Europe were included.
: • Retrospective• Diagnostic/prognostic study• Multicentre study