RT Journal Article
T1 Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy: study protocol for a multicentric randomised clinical trial (TRANSPAIRE).
A1 Sánchez-Velázquez, Patricia
A1 Pueyo-Périz, Eva
A1 Álamo, J M
A1 Suarez Artacho, Gonzalo
A1 Gómez Bravo, Miguel Ángel
A1 Marcello, Manuel
A1 Vicente, Emilio
A1 Quijano, Yolanda
A1 Ferri, Valentina
A1 Caruso, Riccardo
A1 Dorcaratto, Dimitri
A1 Sabater, Luis
A1 González Chávez, Pilarena
A1 Noguera, Jose
A1 Navarro Gonzalo, Ana
A1 Bellido-Luque, Juan
A1 Téllez-Marques, Clara
A1 Ielpo, Benedetto
A1 Burdio, Fernando
K1 Clinical trials
K1 Hepatobiliary surgery
K1 Pancreatic surgery
AB To date, no pancreatic stump closure technique has been shown to be superior to any other in distal pancreatectomy. Although several studies have shown a trend towards better results in transection using a radiofrequency device (radiofrequency-assisted transection (RFT)), no randomised trial for this purpose has been performed to date. Therefore, we designed a randomised clinical trial, with the hypothesis that this technique used in distal pancreatectomies is superior in reducing clinically relevant postoperative pancreatic fistula (CR-POPF) than mechanical closures. TRANSPAIRE is a multicentre randomised controlled trial conducted in seven Spanish pancreatic centres that includes 112 patients undergoing elective distal pancreatectomy for any indication who will be randomly assigned to RFT or classic stapler transections (control group) in a ratio of 1:1. The primary outcome is the CR-POPF percentage. Sample size is calculated with the following assumptions: 5% one-sided significance level (α), 80% power (1-β), expected POPF in control group of 32%, expected POPF in RFT group of 10% and a clinically relevant difference of 22%. Secondary outcomes include postoperative results, complications, radiological evaluation of the pancreatic stump, metabolomic profile of postoperative peritoneal fluid, survival and quality of life. Follow-ups will be carried out in the external consultation at 1, 6 and 12 months postoperatively. TRANSPAIRE has been approved by the CEIM-PSMAR Ethics Committee. This project is being carried out in accordance with national and international guidelines, the basic principles of protection of human rights and dignity established in the Declaration of Helsinki (64th General Assembly, Fortaleza, Brazil, October 2013), and in accordance with regulations in studies with biological samples, Law 14/2007 on Biomedical Research will be followed. We have defined a dissemination strategy, whose main objective is the participation of stakeholders and the transfer of knowledge to support the exploitation of activities. ClinicalTrials.gov Registry (NCT04402346).
YR 2022
FD 2022-11-04
LK http://hdl.handle.net/10668/20149
UL http://hdl.handle.net/10668/20149
LA en
DS RISalud
RD Apr 7, 2025