Benign Pancreas Tumor, Pancreas Cancer, Pancreas Neoplasm, Pancreatic Adenocarcinoma
Conditions
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.
Interventions
None listed
Sponsors
Hospital del Mar
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Sex | Inclusion of the patient in the study | Gender or the patient (Male/Female) |
| 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? |
| 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 |
Countries
Spain
Contacts
Primary ContactIgnasi Poves, Phd, MD
Outcome results
None listed