Role of Nutritional Intervention for the Treatment of Sar... | NCT06814626

Studies
Role of Nutritional Intervention for the Treatment of Sarcopenia in Cirrhotic Patients with Refractory Ascites Candidate to Transjugular Intrahepatic Portosystemic Shunt Placement and Identification of Prognostic Factors Related to Clinical Outcome

NCT06814626

Sponsor

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Status

Recruiting

Last Update Posted

Feb 11, 2025Actual

Enrollment

72Estimated

Phase

Phase 3

Conditions

Liver Cirrhosis
Refractory Ascites in Patients with Cirrhosis
Sarcopenia in Liver Cirrhosis

Interventions

12-week nutritional intervention with Friliver dispensing
12-week nutritional intervention with personalized diet
12-week nutritional intervention with diet diary to report foods eaten.

Countries

Italy
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 13, 2022Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Jan 28, 2025

First Submission Date that Met QC Criteria

Feb 6, 2025

First Posted Date

Feb 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2025

Last Update Posted Date

Feb 11, 2025Actual

Description Module

Brief Summary

The hypothesis is that in patients with cirrhosis and refractory ascites candidate to TIPS, and sarcopenia (identified by a PMA ≤16 cm² at the level of L3), who are at high-risk of 6-month mortality after TIPS placement, a post-TIPS 12 weeks nutritional intervention is associated with improved post-TIPS prognosis.

The primary objective is to evaluate the effect of a post-TIPS 12 weeks nutritional intervention on liver transplant-free six-month survival in sarcopenic candidates to TIPS for refractory ascites in cirrhosis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
12 weeks post-TIPS nutritional dietary intervention	Experimental		Dietary Supplement: 12-week nutritional intervention with Friliver dispensing Other: 12-week nutritional intervention with personalized diet Other: 12-week nutritional intervention with diet diary to report foods eaten.
Standard clinical practice: follow-up post-TIPS placement.	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
12-week nutritional intervention with Friliver dispensing	Dietary Supplement	After TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of survival at 6 months after TIPS assessed using Kaplan-Meier curves. The difference between the survival of the two groups (control and treatment) will be calculated using a Log-Rank test.		From enrollment to 6 months after TIPS.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

men and women with an age ≥ 18 and ≤ 80 years
clinical, radiological or histological diagnosis of liver cirrhosis
diagnosis of RA
confirmation of sarcopenia defined in CT scan as the sum of the psoas muscle areas measured at the level of the 3rd lumbar vertebra (PMA) ≤16 cm2
informed consent signed

Exclusion Criteria:

severe hepatic insufficiency (bilirubin> 5 mg/dl, MELD score> 18, Child-Pugh score> 9)
Congestive heart failure class ≥2 according to New York Heart Association criteria (NYHA)
Active coronary heart disease (myocardial infarction within 6 months of the study)
Severe pulmonary hypertension suspected on echocardiogram (systolic pulmonary arterial pressure [PAPs]> 35 mmHg) and confirmed with right cardiac catheterization (PAPs> 45mmHg)
Chronic renal failure (creatinine> 3 mg/dl)
Performance status ≥2 according to the Eastern Cooperative Oncology Group scale (ECOG)
History of grade III-IV hepatic encephalopathy or West Haven grade I-II hepatic encephalopathy episodes within the last 3 months
Uncontrolled systemic sepsis
Presence of Hepatocellular carcinoma
Complete portal vein thrombosis
Active bleeding from gastroesophageal varices. Patients with adequately treated gastroesophageal varices can be included in the study (banding ligation, sclerotherapy)
Diagnosis of extra hepatic neoplasia
Transplant recipients
Patients unable or unwilling to comply with the protocol requirements
Pregnant or lactating women
Patients unable to autonomously express their consent (incapable patients)
any other laboratory condition or result that in the opinion of the Principal Investigator, preclude the subject's participation in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Angelo Luca, Radiologist	Contact	+39 0912192468		aluca@ismett.edu
Monica Rizzo, Study Coordinator	Contact	+39 0912192692		morizzo@ismett.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione	Recruiting	Palermo		90127	Italy

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001284	Atrophy
D020763	Pathological Conditions, Anatomical
D012816	Signs and Symptoms

ID	Term
D008103	Liver Cirrhosis
D055948	Sarcopenia
D001201	Ascites