Radiofrequency-assisted Transection of the Pancreas vs Stapler

Study Overview
=================
Brief Summary
-----------------
Main objective: The main end-point of this study is to compare in a randomized clinical trial that radiofrequency-assisted pancreas transection (RF) reduces the incidence of postoperative pancreatic fistula (POPF) compared to the classical method of transection (stapler). As secondary end-points, other clinical and demographic variables of the patients will be evaluated (sex, age, ASA classification, consistency of the pancreas, as well as the type of procedure, open or laparoscopic surgery, estimated intraoperative bleeding, pancreatic duct size, duration of intervention, type of tumor and quality of lymphatic resection). Methodology: Phase III prospective multicenter study in patients undergoing distal pancreatectomy for any origin. All consecutive patients who undergo a distal pancreatectomy for any cause in a multicenter setting will be included. A simple randomization of the participants to the RFA group or to the control group (stapler) will be carried out. The incidence of pancreatic fistula will be assessed as main variable; predictive multivariable models with multiple regression for quantitative variables, logistic regression for categorical variables and Cox regression for survival analyzes. In addition to histological study, molecular analysis of resection specimen and clinical and radiological follow-up with volumetry of necrosis in the area of post-pancreatectomy transection will be performed.

Official Title
-----------------
Radiofrequency-assisted Transection of the Pancreas vs Stapler. A Phase III Randomized Clinical Trial.

Conditions
-----------------
Pancreas; Fistula

Intervention / Treatment
-----------------
* Procedure: Radiofrequency-assisted pancreas transection
* Procedure: Stapler assisted pancreas transection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solid or cystic, benign or malign pancreas neoplasms. Patients undergoing a distal pancreatectomy, i.e pancreas transection beyond > 2 cm from the SMV (assessed by computer tomography or RM) with or without splenectomy Both open and laparoscopic approaches are valid. Exclusion Criteria: Patients who required a pancreatectomy with transection at the level of the neck. Non-intervention group: only stapler transection will be accepted, other pancreatic transection methods will be excluded. Patients ASA≥IV Absence of informed consent Underage (<18 years)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency-assisted<br> | Procedure: Radiofrequency-assisted pancreas transection<br>* Transection of the pancreas in distal pancreatectomy by applying a radio frequency device<br>|
| Active Comparator: Stapler<br> | Procedure: Stapler assisted pancreas transection<br>* Transection of the pancreas in distal pancreatectomy by applying a stapler device with/without seamguard<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreas fistula | Defined by the updated 2016 ISGPF definition | 90 days follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital Mortality | 30 days | In-Hospital (30 days) | 
| Morbidity | In terms of Clavien-Dindo and CCI classification | 90 days follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreas fistula, Distal pancreatectomy, Radiofrequency