Purpose: The purpose of this study was to develop and implement a procedure to reduce severe pain from pancreatic cancer due to overactive sympathetic nerve activity using transvascular radiofrequency (RF) nerve ablation.
Materials and Methods: 20 patients with severe abdominal pain from unresectable pancreatic cancer were enrolled and 19 treated with transvascular energy. Angio-CT was used to assess the tumor and plan the procedure. After accessing the vessel through a standard transfemoral or transbrachial approach, transvascular RF energy was delivered via catheter sequentially to multiple sites, including the celiac trunk, common hepatic artery, and/or splenic artery. All treated patients were evaluated within 24 hours, after 24 hours, 7 days, 4-6 weeks, and 3-months post-procedure for the following outcomes: adverse events, pain severity (VAS, 1-10), quality of life assessment (EORTC-30, 0-7), and opioid use.
Results: Responding femoral access procedure patients (N=16) represented 84% of treated patients with a mean pain reduction of 4.16 on the VAS pain scale (baseline of 7.81 to 3.65; 53.3% improvement) at 7-days post-procedure. At 4-6 weeks post-procedure, responding patients (N=9) reported a mean4.67reduction on the VAS pain scale (baseline of7.89 to 3.22), or59.2% improvement. 100% of responding patients were at zero opioid use at 7-days post-procedure (N=16), while 73% were at zero opioid use at 4-6 weeks post-procedure (N=11). In a post hoc analysis of responding patients, pain reduction remained consistent at 3 months post-procedure, with a mean pain reduction of 5.08 (baseline 7.75 to 2.67; 65.6% improvement; N=6). In addition to lasting pain relief, patients (N=7) saw a mean 76.5% improvement in global health, mean 51.5% improvement in functional ability, and mean 50.4% improvement in symptom management. Additionally, 100% of responding patients (N=7) were opioid free at their 3-month post-procedure follow-up.There were no device or procedure-related serious adverse events. The number of patients decreased over time due to natural disease progression, including deaths unrelated to the procedure or device.
Conclusion: RF ablation of the somatosensory nerve via a transfemoral approach to the celiac plexus showed significant, durable pain relief, improved quality of life, and reduced or eliminated opioid use. These promising feasibility results prove that transvascular RF nerve ablation is both safe and effective in reducing severe pain from pancreatic adenocarcinoma.
