Early TIPS in Real Life for Patient Admitted to Intensive Care Unit (REALYTIPS)

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

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).

Study Overview

• Status: Unknown
• Conditions: Esophageal Varicose Veins
• Intervention / Treatment: Procedure: early tips

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to intensive care between 2012 and 2018 for rupture of esophageal varices with cirrhosis Child C≤14 or Child B.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early Tips; Patients wtih early tips for Acute esophageal variceal bleeding	Procedure: early tips; patients with early tips
stantard treatment; patients with standard treatment (medical + endoscopic) for Acute esophageal variceal bleeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival without liver transplantation	Comparison of survival without liver transplantation on day 28 between the two groups.	day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
day 90 mortality	Comparison of recurrence rates of Acute eosophageal variceal bleeding	Comparison of day 90 mortality between the two groups.

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Departmental Hospital Vendee

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: RC19_0422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No