Clinical trial NCT03570502: Incidence of POPF in the Resection of the Left Pancreas With RFAT
Official title: Incidence of Postoperative Pancreatic Fistula in the Resection of the Left Pancreas With a Radiofrequency Assisted Transection Device (RFAT-Pancreas)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreas Neoplasm
Pancreas Cancer
Pancreatic Adenocarcinoma
Benign Pancreas Tumor
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with benign and malignant pancreatic tumours.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pancreatic fistula according the 2016 update of the International Study Group (ISGPS)
timeFrame: 1 month
Secondary outcomes:
measure: Sex
timeFrame: Inclusion of the patient in the study
measure: Age
timeFrame: Inclusion of the patient in the study
measure: Consistency of the pancreas
timeFrame: Inclusion of the patient in the study
measure: Level of jaundice
timeFrame: At the moment of the intervention and during the first week of postoperative period
measure: Type of surgical procedure
timeFrame: Inclusion of the patient in the study
measure: Laparoscopic or open surgery
timeFrame: Inclusion of the patient in the study
measure: Total bleeding
timeFrame: During the intervention
measure: Size of the pancreatic duct
timeFrame: CT scan prior to surgery
measure: Type of tumour
timeFrame: Diagnosis
measure: Postoperative follow-up
timeFrame: 1 year
measure: Type of the postoperative complication
timeFrame: 1 month
measure: Body Mass Index (BMI)
timeFrame: Prior the surgery and during the PO follow-up (1 and 6 months)
measure: Diabetes
timeFrame: Before the precedure and during the PO follow-up (1 and 6 months)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
References:
citation: Burdio F, Dorcaratto D, Hernandez L, Andaluz A, Moll X, Quesada R, Poves I, Grande L, Caceres M, Berjano E. Radiofrequency-induced heating versus mechanical stapler for pancreatic stump closure: in vivo comparative study. Int J Hyperthermia. 2016 May;32(3):272-80. doi: 10.3109/02656736.2015.1136845. Epub 2016 Jan 29.
citation: Malleo G, Vollmer CM Jr. Postpancreatectomy Complications and Management. Surg Clin North Am. 2016 Dec;96(6):1313-1336. doi: 10.1016/j.suc.2016.07.013.
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