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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Parc de Salut Mar de Barcelona- Hospital del Mar
RECRUITING
Barcelona
Contact Information
Primary
Patricia Sánchez-Velázquez, MD PhD FEBS
Psanchezvelazquez@psmar.cat
+34 932483207
Backup
Fernando Burdío, MD PhD
fburdio@hotmail.com
Time Frame
Start Date: 2021-02-15
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 110
Treatments
Experimental: Radiofrequency-assisted
Active_comparator: Stapler
Sponsors
Leads: Patricia Sanchez Velazquez

This content was sourced from clinicaltrials.gov