Pancreas Cancer Clinical Trial
Official title:
Incidence of Postoperative Pancreatic Fistula in the Resection of the Left Pancreas With a Radiofrequency Assisted Transection Device (RFAT-Pancreas)
This study evaluates the impact of the Radiofrequency assisted transection on the rate of postoperative pancreatic fistula (POPF) after performing distal pancreatectomies, central pancreatectomies and pancreatic enucleation
Among the different methods for sealing the remaining pancreas, resection and sealing devices
assisted by radiofrequency energy (RF) have been used, both in experimental studies and in
clinical trials, in order to try to reduce the POPF rate. One of these devices is the
Coolinside®, which is approved for this indication and is currently used in selected cases,
at the Hospital del Mar, among other centers.
Although there are several published studies based on similar technology, the existing
publications on the use of Coolinside® in the pancreas have been made in rat and pig animal
models. In particular, the most recent study published by Dorcaratto et al. compares the
Coolinside device vs. the mechanical stapler in porcine model when performing distal
pancreatectomies. The results suggest that the Coolinside device was more efficient in the
control of the POPF than the stapler with a POPF index of 12% vs. 36%.
Therefore, this study aims to obtain more clinical evidence about the use of Coolinside in
pancreatic resections within a clinical context.
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