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Procedure

TIPS Procedure for Liver Cirrhosis and Muscle Loss

Q: Could you confirm if the enrollment process for this experiment is still open?

Yes, the clinical trial is still taking applications. Per records hosted on clinicaltrials.gov, this study was made available to prospective participants on May 1st 2022 and recently updated as of June 13th 2022.

Q: What are the desired outcomes of this trial?

The main outcome of this research endeavour, measured from the start to six months after enrolment, is changes in body composition. Secondary objectives include evaluating quality of life using a 29-item questionnaire (with grades ranging from 1 - 7), overall survival time and serum ammonia levels.

Q: Does the trial have an age restriction and, if so, is it limited to individuals 35 years or older?

This clinical trial is eligible for patients aged 18 to 99. There are 76 trials specifically targeting minors and 524 for senior citizens.

Q: What are the criteria for being accepted into this research trial?

This medical trial is searching for 22 individuals between 18 and 99 years of age that have sarcopenia. Additionally, it is a requirement that these patients exhibit chronic portal vein thrombosis necessitating recanalization/TIPS for transplantation; gastrointestinal varices with blood loss anemia or past experience of variceal hemorrhage; portal hypertensive gastropathy accompanied by blood loss anemia; cirrhotic conditions wait-listed for liver transplantation; ascites or hydrothorax requiring augmented diuretic medication administration; persistent ascites or hydrothorax in spite of diuretic use, or intolerance to

Q: Could you provide a figure that represents the total amount of subjects taking part in this experiment?

Affirmative, the clinicaltrials.gov repository contains information affirming that this research project is actively searching for participants since its inception on May 1st 2022. According to the latest update from June 13th, only 22 patients need to be recruited at a single medical centre.

Phase < 1

Recruiting

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Portal hypertensive gastropathy and blood loss anemia

Chronic portal vein thrombosis requiring recanalization and TIPS for transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start to 30 days after transplant

Awards & highlights

Study Summary

This trial will test whether TIPS creation leads to improved muscle mass, body composition and muscle function within the first 12 months after the procedure compared to a control group without TIPS, and whether these changes improve liver disease outcomes in patients awaiting liver transplantation.

Who is the study for?

This trial is for adults aged 18-99 with cirrhosis listed for liver transplant, experiencing complications like persistent fluid buildup or bleeding due to portal hypertension. It's not suitable for those with frequent brain function issues from liver disease, severe clotting problems, current infections, pregnancy, urgent need for TIPS, no other treatment options, active cancer outside the liver or a MELD score over 25.Check my eligibility

What is being tested?

The study tests if creating a Transjugular Intrahepatic Portosystemic Shunt (TIPS) in cirrhotic patients improves muscle mass and physical function compared to those without TIPS. The goal is to see if these changes lead to better outcomes while waiting for a liver transplant.See study design

What are the potential side effects?

Potential side effects of TIPS include worsening of brain function issues related to the liver disease (encephalopathy), internal bleeding risks due to altered blood flow in the veins of the esophagus or stomach lining and potential injury during shunt placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have stomach issues due to liver problems and anemia from bleeding.

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I need a procedure to open a blocked vein in my liver for a transplant.

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I am between 18 and 99 years old, have cirrhosis, and am on the liver transplant list.

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I have increased fluid in my abdomen or chest needing more water pills.

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I have ongoing fluid buildup in my abdomen or chest despite using water pills, or I cannot tolerate these pills.

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I have had bleeding from enlarged veins in my stomach or esophagus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start to 30 days after transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start to 30 days after transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and start to 30 days after transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body composition changes

Liver Frailty test

Short Performance Physical Battery test

Secondary outcome measures

Cardiac function

Cardiac mass

Chronic Liver Disease Quality of Life Questionnaire

+5 more

Other outcome measures

IL-6 biomarker assessment

Lipocalin-2 biomarker assessment

Salivary cortisol biomarker assessment

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TIPSExperimental Treatment1 Intervention

Patients in this arm will undergo TIPS creation in addition to their current management.

Group II: Standard of careActive Control1 Intervention

Patients in this arm will continue to be treated with their current management

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,385,890 Total Patients Enrolled

Media Library

Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05420753 — Phase < 1

Liver Cirrhosis Research Study Groups: TIPS, Standard of care

Liver Cirrhosis Clinical Trial 2023: Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation Highlights & Side Effects. Trial Name: NCT05420753 — Phase < 1

Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05420753 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you confirm if the enrollment process for this experiment is still open?

"Yes, the clinical trial is still taking applications. Per records hosted on clinicaltrials.gov, this study was made available to prospective participants on May 1st 2022 and recently updated as of June 13th 2022."

Answered by AI

What are the desired outcomes of this trial?

"The main outcome of this research endeavour, measured from the start to six months after enrolment, is changes in body composition. Secondary objectives include evaluating quality of life using a 29-item questionnaire (with grades ranging from 1 - 7), overall survival time and serum ammonia levels."

Answered by AI

Does the trial have an age restriction and, if so, is it limited to individuals 35 years or older?

"This clinical trial is eligible for patients aged 18 to 99. There are 76 trials specifically targeting minors and 524 for senior citizens."

Answered by AI

What are the criteria for being accepted into this research trial?

"This medical trial is searching for 22 individuals between 18 and 99 years of age that have sarcopenia. Additionally, it is a requirement that these patients exhibit chronic portal vein thrombosis necessitating recanalization/TIPS for transplantation; gastrointestinal varices with blood loss anemia or past experience of variceal hemorrhage; portal hypertensive gastropathy accompanied by blood loss anemia; cirrhotic conditions wait-listed for liver transplantation; ascites or hydrothorax requiring augmented diuretic medication administration; persistent ascites or hydrothorax in spite of diuretic use, or intolerance to"

Answered by AI

Could you provide a figure that represents the total amount of subjects taking part in this experiment?

"Affirmative, the clinicaltrials.gov repository contains information affirming that this research project is actively searching for participants since its inception on May 1st 2022. According to the latest update from June 13th, only 22 patients need to be recruited at a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Body Composition Changes After TIPS and Associated Clinical Outcomes

2022. "Body Composition Changes After TIPS and Associated Clinical Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05420753.

All > Sarcopenia > Cirrhosis