NCT04402346

Radiofrequency-assisted Transection of the Pancreas vs Stapler

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Patricia Sanchez Velazquez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreas; Fistula

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency-assisted pancreas transection	Transection of the pancreas in distal pancreatectomy by applying a radio frequency device
PROCEDURE	Stapler assisted pancreas transection	Transection of the pancreas in distal pancreatectomy by applying a stapler device with/without seamguard

Timeline

• Start date: 2021-02-15
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2020-05-26
• Last updated: 2024-06-07

Locations

1 site across 1 country: Spain