Status:
RECRUITING
Radiofrequency-assisted Transection of the Pancreas vs Stapler
Lead Sponsor:
Patricia Sanchez Velazquez
Conditions:
Pancreas; Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
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 f...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04402346
Start Date
February 15 2021
End Date
June 30 2025
Last Update
June 7 2024
Active Locations (1)
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1
Parc de Salut Mar de Barcelona- Hospital del Mar
Barcelona, Catalonia, Spain, 08019