Esophageal Varicose VeinsREALYTIPSNCT04173299
Early TIPS in Real Life for Patient Admitted to Intensive Care Unit
An observational study of Esophageal Varicose Veins, run by Nantes University Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Esophageal Varicose Veins
- What is being tested?
- early tips
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the 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.
- Conditions
- Esophageal Varicose Veins
- Being tested
- early tips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early tipsProcedure or surgery
patients with early tips
| Study group | Role | What they receive |
|---|---|---|
| Early Tips | Patients wtih early tips for Acute esophageal variceal bleeding Receives: Procedure: early tips | |
| stantard treatment | patients with standard treatment (medical + endoscopic) for Acute esophageal variceal bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival without liver transplantation
Comparison of survival without liver transplantation on day 28 between the two groups.
Measured: day 28
Secondary outcomes (1)
day 90 mortality
Comparison of recurrence rates of Acute eosophageal variceal bleeding
Measured: Comparison of day 90 mortality between the two groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Departemental Vendee
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173299
- Sponsor's protocol ID
- RC19_0422
- Acronym
- REALYTIPS
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Early TIPS Improve Survival for Cirrhotic Patients With Acute Esophageal Variceal Bleeding Admitted in Intensive Care Unit?
- ClinicalTrials.gov ID
- NCT04173299
- Acronym / sponsor ID
- REALYTIPS / RC19_0422
- Conditions
- Esophageal Varicose Veins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Centre Hospitalier Departemental Vendee
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Tips | – | Procedure: early tipsPatients wtih early tips for Acute esophageal variceal bleeding |
| stantard treatment | – | –patients with standard treatment (medical + endoscopic) for Acute esophageal variceal bleeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early tipspatients with early tips | Procedure or surgery | Early Tips |
Primary outcome
survival without liver transplantation
Time frame: day 28
Comparison of survival without liver transplantation on day 28 between the two groups.
1 secondary outcome
day 90 mortality
Time frame: Comparison of day 90 mortality between the two groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Varicose Veins, run by Nantes University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Garret Charlotte, MD (0240084737, charlotte.garret@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival without liver transplantation (time frame: day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.