Background/purpose: The VIO soft-coagulation system (SC) is a new device for tissue coagulation. We hypothesized that this device would be an effective tool for sealing small pancreatic ducts, thus reducing pancreatic fistula following pancreatectomy.
Methods: To confirm whether the SC could be used to seal small pancreatic ducts, we measured the burst pressure in sealed ducts in mongrel dogs. Eight dogs underwent distal pancreatectomy, with the remnant stump coagulated by using the SC. The animals were necropsied on postoperative day 10. In a clinical trial, 11 patients who underwent pancreatoduodenectomy with SC treatment (SC group), and 24 patients who underwent pancreatoduodenectomy without SC treatment (non-SC group) were compared.
Results: In the experimental study, the burst-pressure test revealed that the SC had efficiently sealed the small pancreatic ducts. Histological examination revealed completely obstructed pancreatic ductal structures, ranging from large pancreatic ducts (diameter, 500 microm) to microscopic ducts. No pancreatic leakage was observed following distal pancreatectomy without main pancreatic duct (MPD) suturing in dogs that had an MPD diameter of less than 500 microm. In the clinical trial, pancreatic fistula developed in only one patient (9.1%) in the SC group, but a pancreatic fistula developed in five patients (20.8%) in the non-SC group.
Conclusions: This novel technique using the SC is an effective procedure for preventing the development of pancreatic fistula following pancreatectomy.