Safety of the NiTi EndoCAR Following Chemoradiation in a Porcine Model

Abstract

Purpose. To assess the safety of anastomosis ring (EndoCAR) following chemoradiation. Methods. A total of 10 pigs received radiation to a bioequivalent dose of 4500 cGy with 4 doses of 5-fluorouracil 400 mg/m2 and leucovorin 20 mg/m2 intravenous bolus. On day 21, each animal underwent 2 rectal anastomoses, 10 cm apart, using a 27-mm EndoCAR device and a 29-mm circular stapler. Burst pressures, desmosine and hydroxyproline levels and radiographic leaks were assessed at 2 weeks. Results. In all, 8 pigs were included in the analysis (1 pig died, 1 specimen damaged at harvest). Leaks occurred in 6 (170-300 mm Hg) stapled and 2 ring anastomoses (150-200 mm Hg; P = .13). Internal circumferences were similar (5.5 vs 5.2 cm; P = .5). Desmosine and hydroxyproline levels were similar between groups. Conclusion. Rectal anastomosis, after chemoradiation to the pig rectum using a ring (EndoCAR), is similar to stapled anastomosis. Further trials are needed in humans to determine any clinical advantage associated with these findings.