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临床试验/NCT04559451
NCT04559451Unknown不适用

Assessment of Remnant Liver Function in ALPPS by Gd-EOB-DTPA Enhanced MRI

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Postoperative liver function failure

研究概览

简要总结

Insufficient future liver remnant (FLR), which may render post-hepatectomy liver failure, is one of the major obstacles for performing liver resection for patients with liver malignants. Associating liver partition and portal vein ligation (ALPPS) was introduced to induce rapid and extensive liver hypertrophy, which offers the opportunity for removing the liver malignancy in the second stage operation for patients with insufficient FLR at their first stage operation. Feasibility of the second stage of ALPPS has been assessed mostly on the basis of laboratory parameters and volumetry by the 3D reconstruction of CT. Meanwhile, part of the patients who underwent the second stage ALPPS still experienced postoperative liver failure, even in patients with sufficient FLR volume. In other words, this volumetric increase may not reflect the increase of liver function. And the laboratory parameters can only partly reflect the global liver function but not the regional liver function. Therefore, the combination of volumetric and global liver function tests might be unsuitable for predicting FLR function after first stage ALPPS because function is distributed unequally between left and right liver lobe. The Gd-EOB-DTPA-enhanced liver MRI, which has remarkable potential to evaluate regional liver function and could therefore be an ideal diagnostic test for performing volumetric and functional measurement after the first stage ALPPS in one examination. Thus we performed this clinical trial in order to evaluate the efficacy of Gd-EOB-DTPA-enhanced liver MRI in evaluating the FLR liver function after the first stage ALPPS.

详细描述

The clinical data and follow up information of the patients who underwent laparoscopic ALPPS in Department of General Surgery, Peking University Third Hospital were collected. The indication for the performance of the first and second ALPPS was evaluated by multi-disciplinary team (MDT). The liver function evaluation indexes of Gd-EOB-DTPA Enhanced liver MRI such as RE (Relative enhancement of the liver)=(SI20min-SIunenhanced)/ SIunenhanced and other related indexes were calculated. SI referred to signal intensity. SI20 min referred to the signal intensity in the hepatocyte phase (20 min after the injection). The relationship between the indexes and postoperative liver failure as well as other complications were analyzed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • future liver remnant volume <30%;
  • indocyanine green clearance (ICG) rate <20% at 15 minutes;
  • Child A liver function, serum platelet count > 50×109/L;
  • good general condition.

排除标准

  • complete right portal vein thrombosis;
  • serum platelet count < 50×109/L;
  • clinical signs of portal hypertension such as ascites, and/or intra-abdominal varices.

结局指标

主要结局

Postoperative liver function failure

时间窗: Within 90 days after the operation

The "50-50 criteria" was applied to assess post-treatment liver failure, which considers the increased total bilirubin level (\>50 umol/L) and decreased PTA (\<50%) on postoperative day 5.

次要结局

  • Postoperative morbidities and mortalities(Within 90 days after the operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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