Radiofrequency-assisted Transection of the Pancreas vs Stapler

Not Applicable

Recruiting

• Conditions: Pancreas; Fistula
• Interventions: Procedure: Stapler assisted pancreas transection; Procedure: Radiofrequency-assisted pancreas transection

• Registration Number: NCT04402346
• Lead Sponsor: Patricia Sanchez Velazquez

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Study Start: 2021-02-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapler	Stapler assisted pancreas transection	-
Radiofrequency-assisted	Radiofrequency-assisted pancreas transection	-

Primary Outcome Measures

Name	Time	Method
Pancreas fistula	90 days follow-up	Defined by the updated 2016 ISGPF definition

Secondary Outcome Measures

Name	Time	Method
In-hospital Mortality	In-Hospital (30 days)	30 days
Morbidity	90 days follow-up	In terms of Clavien-Dindo and CCI classification

Trial Locations

Locations (1)

Parc de Salut Mar de Barcelona- Hospital del Mar; 🇪🇸 Barcelona, Cataluña, Spain