跳至主要内容
临床试验/NCT04692259
NCT04692259招募中不适用

Is It Possible To Predict PHLF? - Retrospective Analysis of Gadoxetate MRI Prior To Major Liver Resection

University Hospital, Linkoeping8 个研究点 分布在 4 个国家目标入组 200 人开始时间: 2020年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
8
主要终点
Contrast dynamics of Gadoxetate MRI correlation with the risk of PHLF.

研究概览

简要总结

Post hepatectomy liver failure (PHLF) is one of the most severe complications after liver re-section. Preoperative evaluation of liver function is complicated and imprecise. The volume and function needed for each individual patient is unknown and the methods used for evaluation are uncertain. Preoperative MRI with Gadolinium may give dynamic information regarding liver function correlating with postoperative liver failure. A retrospective analysis will be performed regarding this topic.

详细描述

Post hepatectomy liver failure (PHLF) is one of the most severe complications after liver re-section. Preoperative evaluation of liver function is complicated and imprecise. The volume and function needed for each individual patient is unknown and the methods used for evaluation are uncertain. Arbitrary volume limits have been postulated but still there are patients dying of PHLF with volumes well above these limits.

On multivariate analyses, age ≥70 years, pre-operative chemotherapy, steatosis, resection of >3 segments, vascular reconstruction and intraoperative blood loss >300 mL significantly increased the risk of PHLF. Combining ISGLS grades B and C groups resulted in a high sensitivity for predicting mortality compared to the 50-50 rule and Peak bilirubin >7 mg/dL.

For patients with low volume of the future liver remnant (FLR) there are techniques to in-crease the volume prior to resection. Portal vein embolization (PVE) is an established meth-od, whereas associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is relatively new. Augmentation of the volume of the FLR is indicated for patients with FLR less than 20%, provided no intrinsic liver disease exists, 30% after chemotherapy and 40% for patients with compromised liver function, for example liver cirrhosis.

Both methods, PVE and ALPPS, have high risks of morbidity and mortality, especially post hepatectomy liver failure (PHLF), why other alternatives are evaluated. Liver venous depri-vation (LVD), adds liver vein/s occlusion with a plug/plugs when PVE is performed or after PVE. Preliminary data indicate that the growth rate with this percutaneous method is equivalent to ALPPS with function following in parallel. Still all three methods add one extra treatment stage to increase liver volume of the FLR but still suffers the risk of PHLF. Furthermore, a large group of patients is treated with one stage hepatectomy where the volume and function also may be limited.

Liver volume estimation has been the main method to ensure safe resections, but as many studies have explored functional tests with the goal of increasing safety. The most used ones are Indocyanine green (ICG), maximum liver function capacity (LiMax) , Child Pugh (CP) score and Hepatobiliary scintigraphy (HBS). Still, none of these, alone or in combination have been able to completely ameliorate this dreadful complication. In addition, the cut-off levels for resection for each of these methods are arbitrary, mainly because PHLF is relative-ly rare as are major liver resections. Furthermore, all the tests are time consuming, costly and demanding for the patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Patients who have had a Primovist MRI within 8 weeks before hemihepatectomy or extended hemi-hepatectomy +/- bile duct anastomosis independent of diagnosis.
  • Patients with cirrhosis who have had a Primovist MRI within 8 weeks before resection of more than one liver segment
  • Patients who had liver volume augmentation with a pre-operative Primovist MRI less than 2 weeks before resection
  • Patients who have had a Primovist MRI within 6 weeks be-fore any liver resection where PHLF or death within 90 days occurred.

排除标准

  • <18 years of age
  • Resection was not performed -

结局指标

主要结局

Contrast dynamics of Gadoxetate MRI correlation with the risk of PHLF.

时间窗: 2 years

MRI dynamics correlation with postoperative liver failure. Measurement of gadoxetate uptake pattern in the liver and correlation of this pattern to the risk of developing post hepatectomy liver failure.

次要结局

  • MRI protocol description report on method used MRI protocol description([Time Frame: 2 years)
  • Correlation between preoprative and postoperative risk factors and PHLF(2 years)

研究者

发起方
University Hospital, Linkoeping
申办方类型
Other
责任方
Principal Investigator
主要研究者

Per Sandström

Professor

University Hospital, Linkoeping

研究点 (8)

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