TY - JOUR
T1 - Safety of radiofrequency ablation in patients with locally advanced, unresectable pancreatic cancer: A phase II study
AU - Fegrachi, Samira
AU - Walma, Marieke S.
AU - de Vries, Jan J. J.
AU - van Santvoort, Hjalmar C.
AU - Besselink, Marc G.
AU - von Asmuth, Erik G.
AU - van Leeuwen, Maarten S.
AU - Borel Rinkes, Inne H.
AU - Bruijnen, Rutger C.
AU - de Hingh, Ignace H.
AU - Klaase, Joost M.
AU - Molenaar, I. Quintus
AU - van Hillegersberg, Richard
PY - 2019/11/1
Y1 - 2019/11/1
N2 - 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 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.
AB - 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 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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85067343866&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/31227340
U2 - https://doi.org/10.1016/j.ejso.2019.06.008
DO - https://doi.org/10.1016/j.ejso.2019.06.008
M3 - Article
C2 - 31227340
SN - 0748-7983
VL - 45
SP - 2166
EP - 2172
JO - European Journal of Surgical Oncology
JF - European Journal of Surgical Oncology
IS - 11
ER -