This study, called the OPTIMAL Trial, is for people with advanced liver disease (cirrhosis) and severe obesity, especially those with high pressure in their liver veins (portal hypertension). It's testing if a two-step approach is better than standard medical care. The first step involves a procedure called Transjugular Intrahepatic Portosystemic Shunt (TIPS) to reduce liver vein pressure. A few weeks later, participants would have Sleeve Gastrectomy, a type of weight-loss surgery. Some participants may also receive anti-obesity medications like Semaglutide or Tirzepatide, and lifestyle counseling. The study aims to see if this combined approach improves quality of life, weight loss, and safety. You can join if you are 18-70 years old, have cirrhosis and a BMI between 35-70 kg/m², and are eligible for sleeve gastrectomy. The study is currently recruiting 70 participants.

Study design

This is a single-center, prospective randomized controlled trial comparing a staged approach (TIPS followed by sleeve gastrectomy) to medical management alone, with 70 planned participants.

What's involved

Participants would undergo a TIPS procedure, followed by sleeve gastrectomy 4-6 weeks later. They would also receive lifestyle counseling and potentially anti-obesity medications.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for changes in their physical quality of life at 6 months after treatment begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.