Incidence of POPF in the Resection of the Left Pancreas With RFAT (RFATPancreas)
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|ClinicalTrials.gov Identifier: NCT03570502|
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : June 27, 2018
|Condition or disease|
|Pancreas Neoplasm Pancreas Cancer Pancreatic Adenocarcinoma Benign Pancreas Tumor|
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 [Patient Registry]|
|Estimated Enrollment :||38 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Incidence of Postoperative Pancreatic Fistula in the Resection of the Left Pancreas With a Radiofrequency Assisted Transection Device (RFAT-Pancreas)|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
- Postoperative pancreatic fistula according the 2016 update of the International Study Group (ISGPS) [ Time Frame: 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.
- Sex [ Time Frame: Inclusion of the patient in the study ]Gender or the patient (Male/Female)
- Age [ Time Frame: Inclusion of the patient in the study ]Age of the patient (expressed in years) at the moment of the intervention
- Consistency of the pancreas [ Time Frame: Inclusion of the patient in the study ]It can be defined as "normal", "soft" or "fibrotic"
- Level of jaundice [ Time Frame: 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 [ Time Frame: Inclusion of the patient in the study ]Enucleation, central pancreatectomy or distal pancreatectomy
- Laparoscopic or open surgery [ Time Frame: Inclusion of the patient in the study ]Laparoscopic or open surgery
- Total bleeding [ Time Frame: During the intervention ]Measured during the procedure
- Size of the pancreatic duct [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]Months of follow-up since the pancreatic procedure
- Type of the postoperative complication [ Time Frame: 1 month ]Description of the type of complication
- Body Mass Index (BMI) [ Time Frame: Prior the surgery and during the PO follow-up (1 and 6 months) ]Measured such as: BMI in kg/m^2
- Diabetes [ Time Frame: Before the precedure and during the PO follow-up (1 and 6 months) ]Does the patient has diabetes before or after the precedure?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570502
|Contact: Ignasi Poves, Phd, MD||93 248 32 firstname.lastname@example.org|
|Hospital del Mar||Recruiting|
|Barcelona, Spain, 08003|
|Contact: Ignasi Poves 93 248 32 07 email@example.com|
|Principal Investigator: Ignasi Poves, PhD, MD|
|Sub-Investigator: Fernando Burdío, PhD, MD|
|Sub-Investigator: Dimitri Dorcaratto, PhD, MD|