TIPS and Sleeve Gastrectomy for Portal Hypertension

Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease

Recruiting Phase 4 Interventional Study
Liver Cirrhoses Portal Hypertension Related to Cirrhosis Severe Obesity TIPS
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
The Cleveland Clinic · Other
Who this trial is looking for

This trial is looking for patients with severe obesity and cirrhosis with increased pressure in the veins of the liver. Participants will either receive a special procedure to lower liver pressure followed by weight loss surgery or standard weight management care.

Are You a Good Fit for This Trial?
Rules you out Severe pulmonary diseaseSevere psychiatric illnessDecompensated cirrhosis

You may be able to join if

  • I am between 18 and 70 years old.
  • I have a body mass index (BMI) between 35 and 70.
  • I have liver cirrhosis confirmed by a biopsy or assessment.
  • I have clinically significant portal hypertension.
  • I can give informed consent and follow study procedures.
  • I currently have or have used anti-obesity medications.
  • I am a woman of child-bearing potential and have a negative pregnancy test.
  • I have insurance coverage for metabolic surgery.

You may not be able to join if

  • I have had bariatric or metabolic surgery before.
  • I have had a solid organ transplant.
  • I have severe lung disease.
  • I have severe heart disease or recent heart surgery.
  • I have a history of severe psychiatric illness or substance abuse.
  • I am pregnant, breastfeeding, or not using contraception.
  • I have a serious cancer diagnosis in the last year.
  • I have decompensated cirrhosis.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity. Many patients with cirrhosis also develop a condition called clinically significant portal hypertension (CSPH), which is increased pressure in the veins of the liver. CSPH raises the risk of life-threatening events like internal bleeding and liver failure. Unfortunate…
Trial Locations
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Eligibility Criteria
Inclusion Criteria 1. Is a candidate for general anesthesia 2. Is ≥18 and ≤70 years old at the time of signing the informed consent 3. Has a BMI ≥35 and ≤85 kg/m2 at the time of first study visit 4. Is eligible for metabolic surgery (SG) based on the ASMBS/IFSO 2022 guidelines \[39\] 5. Has insuran…
Contacts

Ghazal F Daftari, MD

857-498-0045

daftarg@ccf.org

CONTACT