Safety of radiofrequency ablation in patients with locally advanced, unresectable pancreatic cancer: A phase II study
Fegrachi, Samira; Walma, Marieke S.; de Vries, Jan J.J.; van Santvoort, Hjalmar C.; Besselink, Marc G.; von Asmuth, Erik G.; van Leeuwen, Maarten S.; Borel Rinkes, Inne H.; Bruijnen, Rutger C.; de Hingh, Ignace H.; Klaase, Joost M.; Molenaar, I. Quintus; van Hillegersberg, Richard
(2019) European Journal of Surgical Oncology, volume 45, issue 11, pp. 2166 - 2172
(Article)
Abstract
Introduction: Radiofrequency ablation (RFA) has been proposed as a new treatment option for locally advanced, unresectable pancreatic cancer (LAPC). In preparation of a randomized controlled trial (RCT), the aim of this phase II study was to assess the safety of RFA for patients with LAPC. Materials and methods: Patients diagnosed
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with LAPC confirmed during surgical exploration between November 2012 and April 2014 were eligible for inclusion. RFA probes were placed under ultrasound guidance with a safety margin of at least 10 mm from the duodenum and 15 mm from the portomesenteric vessels. During RFA, the duodenum was continuously perfused with cold saline to reduce risk for thermal damage. Primary outcome was defined as the amount of major complications (Clavien-Dindo grade ≥III). RFA-related complications were predefined as: pancreatic fistula, pancreatitis, thermal damage to the portomesenteric vessels and duodenal perforation. Results: In total, 17 patients underwent RFA. Delayed gastric emptying (DGE) requiring endoscopic feeding tube placement occurred in 4 patients (24%) as only major complication. Five patients (29%) had a major complication other than DGE. One (6%) RFA-related major complications occurred. One patient (6%) died due to complications from a biliary leak following hepaticojejunostomy. After evaluation of the first 5 patients, gastrojejunostomy was no longer performed routinely. Since then severe DGE seemed to occur less (3/5 vs. 3/12 grade C DGE). Conclusion: RFA is a major, but safe procedure for patients with LAPC if performed with strict predefined safety criteria. A RCT is currently investigating the true effectiveness of RFA in patients with LAPC.
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Keywords: Locally advanced pancreatic cancer, Phase II safety study, Radiofrequency ablation, Surgery, Oncology
ISSN: 0748-7983
Publisher: W.B. Saunders Ltd
Note: Funding Information: The Netherlands Organisation for Scientific Research (NWO) supported S Fegrachi financially during her PhD; nr 017.007.133. This study received material support by Olympus Surgical Technologies consisting of the multipolar CelonLab? POWER System and CelonProSurge? probes. Neither NWO nor Olympus Surgical Technologies had any involvement in the study design, data collection, analysis, interpretation, writing or decision to submit this article for publication. A grant was received from the Dutch Cancer Society (KWF) after the conduction of this study to proceed with a randomized controlled trial on radiofrequency ablation in pancreatic cancer (no. 2014-7444).S Fegrachi is supported by a grant of the Netherlands Organisation for Scientific Research (NWO); nr 017.007.133. MS Walma, IQ Molenaar, MG Besselink and HC van Santvoort received a grant (no. 2014-7444) from KWF for studies on radiofrequency ablation in pancreatic cancer and receive material support by Olympus Surgical Technologies for study purposes. For the remaining authors no conflicts of interests were declared. Funding Information: S Fegrachi is supported by a grant of the Netherlands Organisation for Scientific Research (NWO) ; nr 017.007.133 . MS Walma, IQ Molenaar, MG Besselink and HC van Santvoort received a grant (no. 2014-7444) from KWF for studies on radiofrequency ablation in pancreatic cancer and receive material support by Olympus Surgical Technologies for study purposes. For the remaining authors no conflicts of interests were declared. Publisher Copyright: © 2019
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