Department of Surgery, Hospital del Mar, Barcelona, Spain
Department of Surgery, Hospital del Mar Medical Research Institute, Barcelona, Spain.
BMJ Open. 2022 Nov 4;12(11):e062873. doi: 10.1136/bmjopen-2022-062873.
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).
迄今为止，尚无研究表明哪种胰腺残端闭合技术优于其他技术。尽管有几项研究表明，使用射频设备（射频辅助横断术（RFT））进行横断有更好的趋势，但迄今为止尚未为此目的进行随机试验。因此，我们设计了一项随机临床试验，假设在远端胰腺切除术，与机械闭合相比，该技术在减少临床相关的术后胰瘘（CR-POPF）方面更具优势。
TRANSPAIRE 是一项在西班牙的 7 个胰腺中心进行的多中心随机对照试验，纳入了 112 例因任何原因接受择期远端胰腺切除术的患者，他们将被随机分配至 RFT 或经典吻合器横断术（对照组），比例为 1:1。主要结局为 CR-POPF 发生率。样本量根据以下假设计算：单侧 5%显著性水平（α），80%效能（1-β），对照组预期 POPF 为 32%，RFT 组预期 POPF 为 10%，有临床意义的差异为 22%。次要结局包括术后结果、并发症、胰腺残端的影像学评估、术后腹膜液的代谢组学特征、生存和生活质量。随访将在术后 1、6 和 12 个月在外部会诊中进行。
TRANSPAIRE 已获得 CEIM-PSMAR 伦理委员会的批准。该项目是根据国家和国际指南进行的，符合《赫尔辛基宣言》（2013 年 10 月，巴西福塔雷萨，第 64 届大会）确立的保护人权和尊严的基本原则，以及符合生物样本研究法规，将遵循第 14/2007 号生物医学研究法。我们已经定义了一个传播策略，其主要目标是利益相关者的参与和知识的转移，以支持活动的开发。
ClinicalTrials.gov 注册（NCT04402346）。
