Abstract
Stricture of pancreatic-enteric anastomoses is a major late complication of a pancreaticoduodenectomy for the treatment of a periampullary tumor and can lead to exocrine and endocrine insufficiency such as malnutrition and diabetes mellitus. We investigated the safety and efficacy of a biodegradable tubular stent (BTS) for preventing a pancreaticojejunostomy (PJ) anastomotic stricture in both a rat and porcine model. The BTS was manufactured using a terpolymer comprising poly p-dioxanone, trimethylene carbonate, and glycolide. A cohort of 42 rats was randomized into 7 groups of 6 animals each after BTS placement into the duodenum for the biodegradation assay. A total of 12 pigs were randomized equally into a control and BTS placement group. The effectiveness of the BTS was assessed by comparing radiologic images with histologic results. Surgical procedures and/or BTS placements were technically successful in all animals. The median mass losses of the removed BTS samples from the rat duodenum were 2.1, 6.8, 11.2, 19.4, 26.1, and 56.8% at 1, 2, 3, 4, 6, and 8 weeks, respectively. The BTS had completely degraded at 12 weeks in the rats. In the porcine PJ model, the mean luminal diameter and area of the pancreatic duct in the control group was significantly larger than in the BTS group (all p < 0.05). BTS placement thus appears to be safe and effective procedure for the prevention of PJ anastomotic stricture. These devices have the potential to be used as a temporary stent placement to treat pancreatic-enteric anastomoses, but further investigations are required for optimization in human.
Highlights
The placement of a trans-anastomotic stent is commonly used to manage a pancreaticoenteric anastomosis[14,15]
We have developed a novel biodegradable tubular stent (BTS) and hypothesized that it may reduce the incidence of anastomotic strictures in patients undergoing PD with PJ anastomosis
The BTS devices used in our study were designed and manufactured using a terpolymer consisting of poly p-dioxanone (PDO), trimethylene carbonate (TMC), and glycolide
Summary
The placement of a trans-anastomotic stent is commonly used to manage a pancreaticoenteric anastomosis[14,15]. The stent would provide protection for the PJ anastomosis by facilitating the precise placement of sutures through the pancreatic parenchyma or duct when performing this procedure. It can prevent anastomotic stricture formation at the site of anastomosis late after surgery[16]. We have developed a novel biodegradable tubular stent (BTS) and hypothesized that it may reduce the incidence of anastomotic strictures in patients undergoing PD with PJ anastomosis. The purpose of our present study was to investigate the biodegradable behavior of the BTS in a rat model and further evaluate its safety and efficacy in preventing a PJ anastomotic stricture in a porcine model
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