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

PHASE4RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

February 1, 2029

Study Completion Date

February 1, 2034

Conditions
Liver CirrhosesPortal Hypertension Related to CirrhosisSevere ObesityTIPS
Interventions
PROCEDURE

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Fluoroscopically guided placement of a covered stent creating a portosystemic shunt between hepatic and portal veins. Goal: ≥ 50 % HVPG reduction or final HVPG \< 12 mmHg. Conducted 4-6 weeks (≤ 6 months allowed) before bariatric surgery; standard post-TIPS surveillance ultrasound and EGD to confirm patency and variceal resolution.

PROCEDURE

Sleeve Gastrectomy

Longitudinal resection of \~80 % of stomach via laparoscopic or robotic approach, preserving pylorus. Performed after successful TIPS once portal pressures stabilize (\< 6 months post-TIPS). Standard peri-operative care, micronutrient supplementation, and bariatric follow-up per ASMBS guidelines.

DRUG

Anti-Obesity Pharmacotherapy (Class Effect)

Clinician-selected, evidence-based anti-obesity medications (AOMs) used at the treating provider's discretion. Agents may include incretin-based therapies (e.g., Semaglutide, Tirzepatide) or other FDA-approved AOMs such as Topiramate or Phentermine. Dosing and titration follow standard labeling; no specific drug is mandated. The study assesses the overall class effect of pharmacotherapy rather than any single agent.

BEHAVIORAL

Lifestyle Counseling - Diet & Physical-Activity Program

Regular sessions with a registered dietitian or equivalent (in-person or virtual) focusing on adherence to a reduced-calorie diet, structured physical-activity regimen, and behavior-change strategies. Counseling occurs throughout the 6-month study period and is considered standard care for this patient population.

Trial Locations (1)

44195

RECRUITING

Cleveland Clinic Main Campus, Cleveland

All Listed Sponsors
collaborator

Ali Aminian, MD

UNKNOWN

lead

The Cleveland Clinic

OTHER