The VIPR-1 trial (Visualizing Ischemia in the Pancreatic Remnant) - Assessing the role of intraoperative indocyanine green perfusion of the transected pancreas in predicting postoperative pancreatic leaks: protocol for a prospective phase II trial.

Gustavo Salgado-Garza, Annika Willy, Flavio G. Rocha, Skye C. Mayo, Brett C. Sheppard, Patrick J. Worth
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Abstract

Surgery of the pancreas has come a long way since its inception; however, postoperative morbidity is still high. Pancreatic leaks and fistulas are common complications in patients undergoing surgery to remove the pancreas. Fistulas delay subsequent oncological care after surgery and prolong the hospital stay. Hypoperfusion to the pancreas has been characterized as one factor leading to fistulas. Indocyanine green (ICG) injection allows the surgeon to evaluate blood perfusion to tissue in real-time. This protocol describes a trial that aims to assess the effectiveness of intraoperative ICG metrics of the cut edge of the pancreas to predict postoperative fistulas. A single group will participate in an observational, surgeon-blinded, phase II trial. ICG measurements of the cut edge of the pancreas will be recorded before reconstruction. International Study Group on Pancreatic Surgery criteria for pancreatic fistula will be used to define leaks and fistulas. The primary outcome will be the correlation between ICG measurements and the development or absence of fistula formation. Currently, limited objective intraoperative predictors exist for predicting postoperative fistulas. Having a reliable predictive tool could decrease the healthcare burden posed by fistulas. The findings of this trial will provide conclusions on the usefulness of ICG measurements in predicting postoperative pancreatic fistulas and leaks. This clinical trial is registered in ClinicalTrials.gov with the ID NCT06084013. The current protocol version is v1.0.
VIPR-1试验(胰腺残余缺血可视化)--评估横断胰腺术中吲哚青绿灌注在预测术后胰漏中的作用:前瞻性II期试验方案。
胰腺手术自诞生以来取得了长足的进步,但术后发病率仍然很高。胰漏和瘘管是接受胰腺切除手术的患者常见的并发症。瘘管会延误术后的肿瘤治疗,延长住院时间。胰腺灌注不足是导致瘘管的一个因素。吲哚菁绿(ICG)注射可让外科医生实时评估组织的血液灌注情况。本方案描述了一项旨在评估术中胰腺切缘 ICG 指标预测术后瘘管有效性的试验。一个小组将参与观察性、外科医生盲法的 II 期试验。重建前将记录胰腺切缘的 ICG 测量值。国际胰腺外科研究小组的胰瘘标准将用于定义漏孔和瘘管。主要结果是 ICG 测量值与瘘管形成与否之间的相关性。目前,用于预测术后瘘管的术中客观预测指标有限。拥有可靠的预测工具可以减轻瘘管造成的医疗负担。这项试验的结果将为 ICG 测量在预测术后胰瘘和胰漏方面的实用性提供结论。该临床试验已在 ClinicalTrials.gov 注册,注册号为 NCT06084013。当前方案版本为 v1.0。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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