Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy. Study protocol for a multicentric randomised clinical trial (TRANSPAIRE)

Sánchez Velázquez, Patricia, 1985-; Pueyo Périz, Eva M.; Álamo, M.; Suárez Artacho, Gonzalo; Gómez-Bravo, Miguel Ángel; Marcello, Manuel; Vicente, Emilio; Quijano, Yolanda; Ferri, Valentina; Caruso, Riccardo; Dorcaratto, Dimitri; Sabater, Luis; González Chávez, Pilarena; Noguera, José L.; Navarro Gonzalo, Ana; Bellido-Luque, Juan; Téllez-Marqués, Clara; Ielpo, Benedetto; Burdío Pinilla, Fernando

Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy. Study protocol for a multicentric randomised clinical trial (TRANSPAIRE)

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...

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Autores:	Sánchez Velázquez, Patricia, 1985-, Pueyo Périz, Eva M., Álamo, M., Suárez Artacho, Gonzalo, Gómez-Bravo, Miguel Ángel, Marcello, Manuel, Vicente, Emilio, Quijano, Yolanda, Ferri, Valentina, Caruso, Riccardo, Dorcaratto, Dimitri, Sabater, Luis, González Chávez, Pilarena, Noguera, José L., Navarro Gonzalo, Ana, Bellido-Luque, Juan, Téllez-Marqués, Clara, Ielpo, Benedetto, Burdío Pinilla, Fernando
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2023
País:	España
Institución:	Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:	Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:	oai:recercat.cat:10230/55929
Acceso en línea:	http://hdl.handle.net/10230/55929 http://dx.doi.org/10.1136/bmjopen-2022-062873
Access Level:	acceso abierto
Palabra clave:	Clinical trials Hepatobiliary surgery Pancreatic surgery

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spelling	Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy. Study protocol for a multicentric randomised clinical trial (TRANSPAIRE)Sánchez Velázquez, Patricia, 1985-Pueyo Périz, Eva M.Álamo, M.Suárez Artacho, GonzaloGómez-Bravo, Miguel ÁngelMarcello, ManuelVicente, EmilioQuijano, YolandaFerri, ValentinaCaruso, RiccardoDorcaratto, DimitriSabater, LuisGonzález Chávez, PilarenaNoguera, José L.Navarro Gonzalo, AnaBellido-Luque, JuanTéllez-Marqués, ClaraIelpo, BenedettoBurdío Pinilla, FernandoClinical trialsHepatobiliary surgeryPancreatic surgeryIntroduction: 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.BMJ Publishing Group202320232023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/55929http://dx.doi.org/10.1136/bmjopen-2022-062873reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésCopyright © Sánchez-Velázquez P, Pueyo-Périz E, Álamo JM, Suarez Artacho G, Gómez Bravo MÁ, Marcello M, et al. 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.http://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:10230/559292026-05-29T05:05:01Z
dc.title.none.fl_str_mv	Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy. Study protocol for a multicentric randomised clinical trial (TRANSPAIRE)
title	Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy. Study protocol for a multicentric randomised clinical trial (TRANSPAIRE)
spellingShingle	Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy. Study protocol for a multicentric randomised clinical trial (TRANSPAIRE) Sánchez Velázquez, Patricia, 1985- Clinical trials Hepatobiliary surgery Pancreatic surgery
title_short	Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy. Study protocol for a multicentric randomised clinical trial (TRANSPAIRE)
title_full	Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy. Study protocol for a multicentric randomised clinical trial (TRANSPAIRE)
title_fullStr	Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy. Study protocol for a multicentric randomised clinical trial (TRANSPAIRE)
title_full_unstemmed	Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy. Study protocol for a multicentric randomised clinical trial (TRANSPAIRE)
title_sort	Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy. Study protocol for a multicentric randomised clinical trial (TRANSPAIRE)
dc.creator.none.fl_str_mv	Sánchez Velázquez, Patricia, 1985- Pueyo Périz, Eva M. Álamo, M. Suárez Artacho, Gonzalo Gómez-Bravo, Miguel Ángel Marcello, Manuel Vicente, Emilio Quijano, Yolanda Ferri, Valentina Caruso, Riccardo Dorcaratto, Dimitri Sabater, Luis González Chávez, Pilarena Noguera, José L. Navarro Gonzalo, Ana Bellido-Luque, Juan Téllez-Marqués, Clara Ielpo, Benedetto Burdío Pinilla, Fernando
author	Sánchez Velázquez, Patricia, 1985-
author_facet	Sánchez Velázquez, Patricia, 1985- Pueyo Périz, Eva M. Álamo, M. Suárez Artacho, Gonzalo Gómez-Bravo, Miguel Ángel Marcello, Manuel Vicente, Emilio Quijano, Yolanda Ferri, Valentina Caruso, Riccardo Dorcaratto, Dimitri Sabater, Luis González Chávez, Pilarena Noguera, José L. Navarro Gonzalo, Ana Bellido-Luque, Juan Téllez-Marqués, Clara Ielpo, Benedetto Burdío Pinilla, Fernando
author_role	author
author2	Pueyo Périz, Eva M. Álamo, M. Suárez Artacho, Gonzalo Gómez-Bravo, Miguel Ángel Marcello, Manuel Vicente, Emilio Quijano, Yolanda Ferri, Valentina Caruso, Riccardo Dorcaratto, Dimitri Sabater, Luis González Chávez, Pilarena Noguera, José L. Navarro Gonzalo, Ana Bellido-Luque, Juan Téllez-Marqués, Clara Ielpo, Benedetto Burdío Pinilla, Fernando
author2_role	author author author author author author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	Clinical trials Hepatobiliary surgery Pancreatic surgery
topic	Clinical trials Hepatobiliary surgery Pancreatic surgery
description	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.
publishDate	2023
dc.date.none.fl_str_mv	2023 2023 2023
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	http://hdl.handle.net/10230/55929 http://dx.doi.org/10.1136/bmjopen-2022-062873
url	http://hdl.handle.net/10230/55929 http://dx.doi.org/10.1136/bmjopen-2022-062873
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.rights.none.fl_str_mv	http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess
rights_invalid_str_mv	http://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf application/pdf
dc.publisher.none.fl_str_mv	BMJ Publishing Group
publisher.none.fl_str_mv	BMJ Publishing Group
dc.source.none.fl_str_mv	reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str	Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str	Recercat. Dipósit de la Recerca de Catalunya
collection	Recercat. Dipósit de la Recerca de Catalunya
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Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy. Study protocol for a multicentric randomised clinical trial (TRANSPAIRE)

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