دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy: study protocol for a multicentric randomised clinical trial (TRANSPAIRE).
المؤلفون: Sánchez-Velázquez P; Department of Surgery, Hospital del Mar, Barcelona, Spain psanchezvelazquez@psmar.cat.; Department of Surgery, Hospital del Mar Medical Research Institute, Barcelona, Spain., Pueyo-Périz E; Department of Surgery, Hospital del Mar Medical Research Institute, Barcelona, Spain., Álamo JM; Department of Surgery, University Hospital Virgen del Rocío, Sevilla, Spain., Suarez Artacho G; Department of Surgery, University Hospital Virgen del Rocío, Sevilla, Spain., Gómez Bravo MÁ; Department of Surgery, University Hospital Virgen del Rocío, Sevilla, Spain., Marcello M; Department of Surgery, Alcorcon Hospital Foundation, Alcorcon, Spain., Vicente E; Department of Surgery, Hospital Universitario Sanchinarro, Madrid, Spain., Quijano Y; Department of Surgery, Hospital Universitario Sanchinarro, Madrid, Spain., Ferri V; Department of Surgery, Hospital Universitario Sanchinarro, Madrid, Spain., Caruso R; Department of Surgery, Hospital Universitario Sanchinarro, Madrid, Spain., Dorcaratto D; Liver, Biliary and Pancreatic Unit, Department of General Surgery. Biomedical Research Institute INCLIVA, Hospital Clínico Valencia, Valencia, Spain., Sabater L; Liver, Biliary and Pancreatic Unit, Department of General Surgery. Biomedical Research Institute INCLIVA, Hospital Clínico Valencia, Valencia, Spain., González Chávez P; Hospital Virgen de la Candelaria, Tenerife, Spain., Noguera J; Hospital Juan Canalejo de La Coruña, A Coruña, Spain., Navarro Gonzalo A; Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain., Bellido-Luque J; Hospital Universitario Virgen Macarena, Sevilla, Spain., Téllez-Marques C; Department of Surgery, Hospital del Mar, Barcelona, Spain., Ielpo B; Department of Surgery, Hospital del Mar Medical Research Institute, Barcelona, Spain.; Parc Salut Mar Hospital, Barcelona, Spain., Burdio F; Department of Surgery, Hospital del Mar Medical Research Institute, Barcelona, Spain.
المصدر: BMJ open [BMJ Open] 2022 Nov 04; Vol. 12 (11), pp. e062873. Date of Electronic Publication: 2022 Nov 04.
نوع المنشور: Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Pancreatectomy*/adverse effects , Pancreatectomy*/methods, Humans ; Multicenter Studies as Topic ; Pancreas/surgery ; Pancreatic Fistula/etiology ; Pancreatic Fistula/prevention & control ; Postoperative Complications/etiology ; Quality of Life ; Randomized Controlled Trials as Topic ; Risk Factors
مستخلص: 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.
Registration Details: ClinicalTrials.gov Registry (NCT04402346).
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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فهرسة مساهمة: Keywords: Clinical trials; Hepatobiliary surgery; Pancreatic surgery
سلسلة جزيئية: ClinicalTrials.gov NCT04402346
تواريخ الأحداث: Date Created: 20221104 Date Completed: 20221115 Latest Revision: 20221120
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC9639090
DOI: 10.1136/bmjopen-2022-062873
PMID: 36332946
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2022-062873