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

Hospital del Mar38 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreas Neoplasm Pancreas Cancer Pancreatic Adenocarcinoma Benign Pancreas Tumor

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with benign or malignant lesions of the pancreas * Subjected to distal, central pancreatectomy or enucleations of the left pancreas * Patients ASA (American Society of Anesthesiologists I-III * Open or laparoscopic approach. Exclusion Criteria: * ASA ≥IV patients * Patients with limitrophic or neuroendocrine lesions

Locations (1)

Hospital del Mar

Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Postoperative pancreatic fistula according the 2016 update of the International Study Group (ISGPS)

"Grade A postoperative pancreatic fistula" is now redefined and called a "biochemical leak," because it has no clinical importance and is no longer referred to a true pancreatic fistula. Postoperative pancreatic fistula grades B and C are confirmed but defined more strictly. In particular, grade B requires a change in the postoperative management; drains are either left in place \>3 weeks or repositioned through endoscopic or percutaneous procedures. Grade C postoperative pancreatic fistula refers to those postoperative pancreatic fistula that require reoperation or lead to single or multiple organ failure and/or mortality attributable to the pancreatic fistula.

Time frame: 1 month

Secondary Outcomes

Sex

Gender or the patient (Male/Female)

Time frame: Inclusion of the patient in the study

Age

Age of the patient (expressed in years) at the moment of the intervention

Time frame: Inclusion of the patient in the study

Consistency of the pancreas

It can be defined as "normal", "soft" or "fibrotic"

Time frame: Inclusion of the patient in the study

Level of jaundice

Bilirubin level at the moment of the intervention and during the first week of postoperative period

Time frame: At the moment of the intervention and during the first week of postoperative period

Type of surgical procedure

Enucleation, central pancreatectomy or distal pancreatectomy

Time frame: Inclusion of the patient in the study

Central Contacts

Ignasi Poves, Phd, MD

CONTACT

93 248 32 07 ipoves@parcdesalutmar.ca

Data from ClinicalTrials.gov

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