Radiofrequency-assisted Transection of the Pancreas vs Stapler

Pancreas; Fistula Clinical Trial

— TRANSPAIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04402346
• Other study ID #: HMar_RF_transection_pancreas
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Hospital del Mar
• Contact: Patricia Sánchez-Velázquez, MD PhD FEBS
• Phone: +34 932483207
• Email: Psanchezvelazquez[@]psmar.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fistula
• Pancreas; Fistula
• Pancreatic Fistula

Intervention

Procedure:
• Radiofrequency-assisted pancreas transection
Transection of the pancreas in distal pancreatectomy by applying a radio frequency device
• Stapler assisted pancreas transection
Transection of the pancreas in distal pancreatectomy by applying a stapler device with/without seamguard

Locations

Country	Name	City	State
Spain	Parc de Salut Mar de Barcelona- Hospital del Mar	Barcelona	Cataluña

Sponsors (1)

Lead Sponsor	Collaborator
Patricia Sanchez Velazquez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreas fistula	Defined by the updated 2016 ISGPF definition	90 days follow-up
Secondary	In-hospital Mortality	30 days	In-Hospital (30 days)
Secondary	Morbidity	In terms of Clavien-Dindo and CCI classification	90 days follow-up