Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy: study protocol for a multicentric randomised clinical trial (TRANSPAIRE)
Sánchez-Velázquez, Patricia (Universitat Autònoma de Barcelona. Departament de Cirurgia)
Pueyo-Périz, Eva (Universitat Autònoma de Barcelona. Departament de Cirurgia)
Álamo, J M. (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Suarez Artacho, Gonzalo (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Gómez-Bravo, Miguel A. (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Marcello, Manuel (Hospital Universitario Fundación Alcorcón)
Vicente, Emilio (Hospital Universitario HM Sanchinarro (Madrid))
Quijano, Yolanda (Hospital Universitario HM Sanchinarro (Madrid))
Ferri, Valentina (Hospital Universitario HM Sanchinarro (Madrid))
Caruso, Riccardo (Hospital Universitario HM Sanchinarro (Madrid))
Dorcaratto, Dimitri (Hospital Clínic Universitari (València))
Sabater, Luis (Hospital Clínic Universitari (València))
González Chávez, Pilarena (Hospital Universitario Nuestra Señora de Candelaria (Santa Cruz de Tenerife))
Noguera, Jose (Hospital Juan Canalejo de la Coruña)
Navarro Gonzalo, Ana (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Bellido-Luque, Juan (Hospital Universitario Virgen Macarena (Sevilla, Andalusia))
Téllez-Marques, Clara (Hospital del Mar (Barcelona, Catalunya))
Ielpo, Benedetto (Parc de Salut MAR de Barcelona)
Burdío, Fernando (Universitat Autònoma de Barcelona. Departament de Cirurgia)

Data:	2022
Resum:	Introduction 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. Methods and analysis 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. Ethics and dissemination 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.
Ajuts:	Instituto de Salud Carlos III PI20/00008
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	BMJ open, Vol. 12 Núm. 11 (2022) , ISSN 2044-6055

DOI: 10.1136/bmjopen-2022-062873
PMID: 36332946

7 p, 372.9 KB

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