Using TIPS before sleeve gastrectomy to improve outcomes for people with cirrhosis and severe obesity

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

This trial tests whether placing a TIPS (a portal decompression procedure) before sleeve gastrectomy helps adults with cirrhosis, clinically significant portal hypertension, and severe obesity lose weight, feel better, and have fewer complications.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT07058155 on ClinicalTrials.gov

What this trial studies

The OPTIMAL trial is a single-center, randomized controlled trial that will enroll 70 adults with cirrhosis, clinically significant portal hypertension, and BMI 35–70 kg/m² to compare a staged strategy (TIPS placement followed by sleeve gastrectomy) versus optimized medical management with anti-obesity medication and lifestyle counseling. Participants are randomized and followed for outcomes including health-related quality of life, weight loss, and procedure-related safety and complications. The protocol permits current or prior anti-obesity medication use and requires surgical eligibility per guidelines and insurance coverage for metabolic surgery. The trial aims to determine whether preoperative portal decompression reduces operative risk and improves longer-term metabolic and hepatic outcomes compared with non-surgical management.

Who should consider this trial

Good fit: Ideal candidates are adults 18–70 years old with biopsy-proven or noninvasively confirmed cirrhosis, clinically significant portal hypertension, BMI 35–70 kg/m², eligibility for sleeve gastrectomy per guidelines, and coverage for metabolic surgery.

Not a fit: Patients with prior complex foregut surgery or prior bariatric surgery exclusions, history of solid-organ transplant, very advanced decompensated liver disease, or severe pulmonary impairment are unlikely to benefit or be eligible for this approach.

Why it matters

Potential benefit: If successful, the approach could reduce surgical risk, improve sustained weight loss and quality of life, and broaden safe treatment options for people with cirrhosis and severe obesity.

How similar studies have performed: Small retrospective series suggest that TIPS before bariatric surgery may reduce operative risk, but no prior prospective randomized trial has tested this staged strategy.

Eligibility criteria

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.

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic Main Campus — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Sobia Laique, MD — The Cleveland Clinic
• Study coordinator: Awwab F Hammad, MD

Conditions Liver Cirrhoses; Portal Hypertension Related to Cirrhosis; Severe Obesity; TIPS; Sleeve Gastrectomy; Transjugular Intrahepatic Portosystemic Shunt; Bariatric Surgery / Metabolic Surgery; Clinically Significant Portal Hypertension