NCT03570502

Incidence of POPF in the Resection of the Left Pancreas With RFAT

Incidence of Postoperative Pancreatic Fistula in the Resection of the Left Pancreas With a Radiofrequency Assisted Transection Device (RFAT-Pancreas)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 38 (estimated)
• Sponsor: Hospital del Mar · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pancreas Neoplasm
• Pancreas Cancer
• Pancreatic Adenocarcinoma
• Benign Pancreas Tumor

Timeline

• Start date: 2016-11-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2018-06-27
• Last updated: 2018-06-27

Locations

1 site across 1 country: Spain