What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Transjugular Intrahepatic Portosystemic Shunt (TIPS), Sleeve Gastrectomy, or Anti-Obesity Pharmacotherapy (Class Effect). The registry lists allocation as randomized. Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity.
They plan to enroll about 70 people at Cleveland. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app), a procedure as part of the study plus check-ins.
Official title (unrewritten)
OPTIMAL Trial: Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Interventions: Transjugular Intrahepatic Portosystemic Shunt (TIPS), Sleeve Gastrectomy, Anti-Obesity Pharmacotherapy (Class Effect), Lifestyle Counseling - Diet & Physical-Activity Program
Primary outcome (registry wording): Change in SF-36 Physical Component Summary (PCS) Score From Baseline to 6 Months