Both arterial and venous thromboembolism are common complications of pancreatic cancer, and mesenteric venous thrombosis (MVT) is also a common incidental finding in patients with pancreatic cancer. Trans-arterial micro perfusion (TAMP) is a new investigational procedure providing local delivery of gemcitabine to treat locally advanced pancreatic cancer (LAPC). In an ongoing Phase 3 randomized clinical trial testing the efficacy of TAMP (TIGeR-PaC, NCT03257033), up to 8 bi-monthly treatments are provided, during which an artery in the vicinity of the tumor is occluded by a double-balloon catheter for 20 minutes. We postulated the presence of MVT on pre-randomization baseline abdominal CT imaging could predict the occurrence of arterial thrombosis associated with TAMP. The results of an interim analysis comparing the incidence of thrombosis in patients with or without MVT are presented. Consecutive subjects randomized to TAMP treatment were included in the analysis. The presence or absence of MVT on baseline CT was determined by a core imaging center radiologist. The outcomes examined were 1) Inability to complete the planned 8-cycles of TAMP; 2) Target vessel thrombosis during or after TAMP; and 3) Procedural pain or discomfort. Statistical analysis was performed using the Student's t-test. Of the 25 subjects randomized to TAMP therapy, 11 failed to complete 8 cycles of treatment. Target vessel thrombosis prevented completion of the 8 cycles of treatment in 6/11 subjects. Among those 6 subjects, the prevalence of MVT on baseline abdominal CT imaging was 100% (6/6), as compared to 57% (8/14) among subjects who were able to complete the 8 cycles of therapy and did not develop arterial thrombosis (P = 0.004). In addition, the incidence of procedural nausea and vomiting was more common in patients with MVT (57%) than in those without MVT (18%) (P = 0.003). In patients with LAPC receiving TAMP treatment with gemcitabine, MVT on baseline CT imaging is a strong predictor of target artery thrombosis. Furthermore, procedural abdominal pain and nausea, likely due to ischemia, are more common in patients with MVT than in those without MVT.
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