Feasibility and safety of endoscopic cryoablation at the duodenal papilla: Porcine model.

Abstract

To assess the feasibility and safety of liquid nitrogen spray cryoablation at the duodenal papilla in a porcine model. This prospective study protocol was approved by the University of Florida Institutional Animal Care and Use Committee. Six pigs underwent liquid nitrogen spray cryotherapy at the duodenal papilla. Freeze time of 20-s was applied per cycle (4 cycles/session). Survival animals (n = 4) were monitored for adverse events. Hemoglobin, white blood count, liver tests, and lipase were obtained at baseline and post-treatment. EGD was performed on day#7 to evaluate the papilla and for histology. All animals were euthanized and necropsy was performed at the end of the one-week survival period. Feasibility was defined as successful placement of the decompression tube in the duodenum, followed by delivery of spray cryotherapy to the duodenal papilla. Safety was determined by monitoring post-treatment blood tests and clinical course. Treatment effect was defined as endoscopic and histologic changes after cryotherapy. This was established by comparing endoscopic and histologic findings from mucosal biopsies prior to cryotherapy and on post-operative day (POD)#7. Full-thickness specimen was obtained post-mortem to assess depth of injury. Spray cryotherapy was feasible and successfully performed in all 6/6 (100%) animals. Cryospray with liquid nitrogen (four 20-s freeze-thaw cycles) at the duodenal papilla resulted in white frost formation at and around the target region. The mean procedural time was 54.5 min (range 50-58 min). All six animals studied had stable blood pressure, heart rate, and pulse oximetry measurements during the procedure. There were no significant intra-procedural adverse events. There were no significant differences in hemoglobin, white cell count, liver tests or lipase from baseline to post-cryotherapy. Survival animals were monitored daily post-operatively without any clinical ill effects from the cryotherapy. There was no bleeding, infection, or perforation on necropsy. Endoscopic on POD#7 showed edema and ulceration at the duodenal papilla. On histology, there was loss of crypt architecture with moderate to severe necrosis and acute mixed inflammatory infiltration in each specimen following cryotherapy. The extent of cryogen-induced tissue necrosis (depth of injury) was limited to the mucosa on full-thickness specimen evaluation. Endoscopic liquid nitrogen spray cryotherapy is feasible and safe for ablation at the duodenal papilla in a porcine model.