Study S001073

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

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT07058155
Acronym: OPTIMAL
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: RECRUITING
Enrollment: 70
Start: 2025-12-17
Primary completion: 2029-02-01
Lead sponsor: The Cleveland Clinic
Conditions: Liver Cirrhoses; Portal Hypertension Related to Cirrhosis; Severe Obesity; TIPS
Interventions: PROCEDURE:Transjugular Intrahepatic Portosystemic Shunt (TIPS); PROCEDURE:Sleeve Gastrectomy; DRUG:Anti-Obesity Pharmacotherapy (Class Effect); BEHAVIORAL:Lifestyle Counseling - Diet & Physical-Activity Program
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Change in SF-36 Physical Component Summary (PCS) Score From Baseline to 6 Months [At 6 months after treatment initiation (Day 0 = TIPS placement date or start of medical management).]

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