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临床试验/NCT04173299
NCT04173299Unknown不适用

Does Early TIPS Improve Survival for Cirrhotic Patients With Acute Esophageal Variceal Bleeding Admitted in Intensive Care Unit?

Nantes University Hospital0 个研究点目标入组 100 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
survival without liver transplantation

研究概览

简要总结

Acute esophageal variceal bleeding (AEVB) is a serious complication of cirrhosis, with high morbidity and mortality. The latest European recommendations(1) recommend the early implementation, within 72 hours following esophageal variceal bleeding, of a transhepatic porto-systemic shunt set up by transjugular route (TIPS) called "early TIPS" in patients at high risk of recurrence, i.e. Child C<14 or Child B with active bleeding at the time of endoscopy. The implementation of early TIPS appears to improve survival without transplantation in these patients, although the benefit among Child B patients without active bleeding has yet to be demonstrated.

Renal failure is a determining factor in the prognosis of the cirrhotic patient. For patients with refractory ascites, or type 2 hepato-renal syndrome (i.e. chronic renal failure related to portal hypertension), the use of TIPS is recommended. Although a few studies with low levels of evidence have reported a benefit in the placement of TIPS in hepato-renal syndrome type 1 (i.e. acute renal failure related to portal hypertension), the European recommendations do not recommend the use of TIPS in this context due to lack of studies on the subject. Some studies have shown an improvement in renal function after performing TIPS in refractory ascites. To date, no studies have evaluated the impact of the implementation of early-TIPS on renal function in intensive care patients.

The investigators would like to evaluate the impact on survival without liver transplantation on D28 of the implementation of early-TIPS in cirrhotic patients with AEVB requiring ICU hospitalization, compared to standard treatment (medical and endoscopic).

详细描述

Using electronic patient data monitoring systems, the investigators reviewed all patients with a diagnosis of cirrhosis admitted to ICUs at the Nantes University Hospital, and departmental Hospital of Vendée from January 1, 2012, to december 31, 2018. For enrolled patients, general clinical characteristics were collected. Patients were categorized into two groups according to the type of treatment performed: early TIPS or standard treatment.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Adult patients (age >18 years) with cirrhosis Admitted in Intensive Care Unit Cirrhosis Child B or Child C With Acute esophageal variceal bleeding confirmed by endoscopy.

排除标准

  • Patients under guardianship Patients with a decision to limit care at the admission Patients with already a TIPS. Patients with a invasive multifocal hepatocellular carcinoma pregnancy

结局指标

主要结局

survival without liver transplantation

时间窗: day 28

Comparison of survival without liver transplantation on day 28 between the two groups.

次要结局

  • day 90 mortality(Comparison of day 90 mortality between the two groups.)

研究者

申办方类型
Other
责任方
Sponsor

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