New combo treatment aims to help patients with liver disease and obesity
NCT ID NCT07058155
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a two-step procedure can help people with advanced liver disease and severe obesity. First, a TIPS procedure lowers pressure in the liver veins. Then, sleeve gastrectomy surgery helps with weight loss. The study compares this approach to standard medical care. Researchers will track quality of life and weight loss over 6 months in 70 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TIPS procedure and sleeve gastrectomy surgery
- What this could lead to
- If successful, this could offer a new, safe treatment path for people with both advanced liver disease and severe obesity who currently have few options.
- What could go wrong
- This is a small, early-phase trial with only 70 participants, so results may not apply to everyone. Both procedures carry risks like bleeding, infection, or liver complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Feb 2034
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Candidate for general anesthesia. 2. Age 18-70 years at consent. 3. BMI 35-70 kg/m² at first study visit. 4. Eligible for sleeve gastrectomy per ASMBS/IFSO 2022 guidelines. 5. Insurance coverage for metabolic surgery. 6. Current or prior anti-obesity medication use permitted. 7. Liver cirrhosis confirmed by biopsy or non-invasive assessment. 8. Clinically significant portal hypertension (HVPG ≥ 10 mm Hg, or esophagogastric varices / portal-hypertensive gastropathy, or imaging evidence of collaterals/dilated portal vein). 9. Able and willing to provide informed consent and comply with study procedures. 10. Women of child-bearing potential: negative urine pregnancy test at screening and randomization and agreement to reliable contraception for 2 years. Exclusion Criteria 1. Prior bariatric/metabolic surgery (except removed devices ≥ 3 months earlier). 2. Prior complex foregut surgery. 3. History of solid-organ transplant. 4. Severe pulmonary disease (FEV1 \< 50 % predicted). 5. Significant cardiac or atherosclerotic disease with planned re-vascularization within 12 months. 6. ASA class IV or V uncompensated cardiopulmonary disease. 7. Left-ventricular ejection fraction \< 25 % or MI/unstable angina/stroke/heart surgery/coronary stent within 6 months. 8. Hiatal hernia \> 7 cm or LA grade C/D erosive esophagitis. 9. Active Crohn's disease. 10. Severe psychiatric illness, dementia, active psychosis, history of suicide attempt, or alcohol/substance abuse within 12 months. 11. Pregnant, breastfeeding, planning pregnancy, or not using adequate contraception. 12. Malignancy within the prior 12 months (except non-melanoma skin cancer). 13. Life expectancy \< 2 years in investigator's judgment. 14. Investigational therapy within 3 months. 15. Acute pancreatitis ≤ 90 days. 16. Portal vein thrombosis at screening. 17. Decompensated cirrhosis (moderate/large ascites, hepatic encephalopathy, or listed for liver transplant); small ascites or prior variceal bleed allowed. 18. Total bilirubin \> 3 mg/dL, INR \> 1.7, or platelets \< 50 000/µL (within 1 month). 19. Significant alcohol intake (\> 14 units/week women, \> 21 units/week men) within the prior 12 months. 20. eGFR \< 45 mL/min/1.73 m² or on dialysis (within 1 month). 21. AIDS. 22. Unable to understand study or give consent. 23. Plans to move more than 3 hours from Cleveland within 6 months. 24. Previous randomization in this trial. 25. Any condition that, in the investigator's opinion, places the subject at undue risk.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic Main Campus
RECRUITINGCleveland, Ohio, 44195, United States
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