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2016-11
2021-04
2021-04
38
NCT03570502
Hospital del Mar
Hospital del Mar
OBSERVATIONAL
Incidence of POPF in the Resection of the Left Pancreas With RFAT
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-05-17 | N/A | 2018-06-15 |
2018-06-15 | N/A | 2018-06-27 |
2018-06-27 | N/A | 2018-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | 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 | 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) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Ignasi Poves, Phd, MD Phone Number: 93 248 32 07 Email: ipoves@parcdesalutmar.ca |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
