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

Esophageal Varicose Veins Clinical Trial

— REALYTIPS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04173299
• Other study ID #: RC19_0422
• Status: Not yet recruiting
• Start date: December 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: November 2019
• Source: Nantes University Hospital
• Contact: Garret Charlotte, MD
• Phone: 0240084737
• Email: charlotte.garret[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Varicose Veins
• Varicose Veins

Intervention

Procedure:
• early tips
patients with early tips

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Departmental Hospital Vendee

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival without liver transplantation	Comparison of survival without liver transplantation on day 28 between the two groups.	day 28
Secondary	day 90 mortality	Comparison of recurrence rates of Acute eosophageal variceal bleeding	Comparison of day 90 mortality between the two groups.