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

• Conditions: Benign Pancreas Tumor; Pancreas Neoplasm; Pancreatic Adenocarcinoma; Pancreas Cancer

• Registration Number: NCT03570502
• Lead Sponsor: Hospital del Mar

Brief 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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2018-05-17
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-15
• Last Update Submitted: 2018-06-15
• Study First Posted: 2018-06-27
• Last Update Posted: 2018-06-27
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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.

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Exclusion Criteria

• ASA ≥IV patients
• Patients with limitrophic or neuroendocrine lesions

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pancreatic fistula according the 2016 update of the International Study Group (ISGPS)	1 month	"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.

Secondary Outcome Measures

Name	Time	Method
Sex	Inclusion of the patient in the study	Gender or the patient (Male/Female)
Age	Inclusion of the patient in the study	Age of the patient (expressed in years) at the moment of the intervention
Consistency of the pancreas	Inclusion of the patient in the study	It can be defined as "normal", "soft" or "fibrotic"
Level of jaundice	At the moment of the intervention and during the first week of postoperative period	Bilirubin level at the moment of the intervention and during the first week of postoperative period
Type of surgical procedure	Inclusion of the patient in the study	Enucleation, central pancreatectomy or distal pancreatectomy
Laparoscopic or open surgery	Inclusion of the patient in the study	Laparoscopic or open surgery
Total bleeding	During the intervention	Measured during the procedure
Size of the pancreatic duct	CT scan prior to surgery	Size of the main pancreatic duct expressed in mm, measured on the last CT before the procedure
Type of tumour	Diagnosis	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
Postoperative follow-up	1 year	Months of follow-up since the pancreatic procedure
Type of the postoperative complication	1 month	Description of the type of complication
Body Mass Index (BMI)	Prior the surgery and during the PO follow-up (1 and 6 months)	Measured such as: BMI in kg/m\^2
Diabetes	Before the precedure and during the PO follow-up (1 and 6 months)	Does the patient has diabetes before or after the precedure?

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain