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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreas Neoplasm, Pancreas Cancer, Pancreatic Adenocarcinoma, Benign Pancreas Tumor

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex | Gender or the patient (Male/Female) | Inclusion of the patient in the study | 
| Age | Age of the patient (expressed in years) at the moment of the intervention | Inclusion of the patient in the study | 
| Consistency of the pancreas | It can be defined as normal, soft or fibrotic | 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 | At the moment of the intervention and during the first week of postoperative period | 
| Type of surgical procedure | Enucleation, central pancreatectomy or distal pancreatectomy | Inclusion of the patient in the study | 
| Laparoscopic or open surgery | Laparoscopic or open surgery | Inclusion of the patient in the study | 
| Total bleeding | Measured during the procedure | During the intervention | 
| Size of the pancreatic duct | Size of the main pancreatic duct expressed in mm, measured on the last CT before the procedure | CT scan prior to surgery | 
| Type of tumour | Serous cystadenoma Acinar cystadenoma Ductal adenocarcinoma Acinar cell carcinoma Cystadenocarcinoma of acinar cells Intraductal papillary mucinous neoplasia associated with invasive carcinoma Mixed carcinoma (ductal-neuroendocrine or acinar-neuroendocrine) Cystic mucinous neoplasia associated with invasive carcinoma Pancreatoblastoma Serous cystadenocarcinoma Pseudopapillary-solid neoplasia | Diagnosis | 
| Postoperative follow-up | Months of follow-up since the pancreatic procedure | 1 year | 
| Type of the postoperative complication | Description of the type of complication | 1 month | 
| Body Mass Index (BMI) | Measured such as: BMI in kg/m^2 | Prior the surgery and during the PO follow-up (1 and 6 months) | 
| Diabetes | Does the patient has diabetes before or after the precedure? | Before the precedure and during the PO follow-up (1 and 6 months) |