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

NCT04173299 | Unknown

• 1 other identifier: RC19_0422
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Esophageal Varicose Veins

Outcome Measures

Primary Outcomes (1)

• survival without liver transplantation

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

  day 28

Secondary Outcomes (1)

• day 90 mortality

  Comparison of day 90 mortality between the two groups.

Study Arms (2)

Early Tips

Patients wtih early tips for Acute esophageal variceal bleeding

Procedure: early tips

stantard treatment

patients with standard treatment (medical + endoscopic) for Acute esophageal variceal bleeding

Interventions

early tips PROCEDURE

patients with early tips

Early Tips

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Departmental Hospital Vendee: collaborator

Central Study Contacts

Garret Charlotte, MD

CONTACT

0240084737; charlotte.garret@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 21, 2019
• Study Start: December 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: March 1, 2020
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share