Prognostic Role of HVPG and ICG-R15 in the Short- and Medium-term Results of the Surgery of HCC on Cirrhosis

NCT05800561 | Unknown

• 1 other identifier: 368/20
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

AIMS To evaluate the accuracy of HVPG (direct method), ICG-R15 and LSM/SSM (non-invasive methods) in predicting the risk of PHLF and hepatic decompensation; to evaluate the correlation between hepatic functional reserve (ICG-R15) and degree of portal hypertension (HVPG) and LSM/SSM in Child Pugh 0, A and B cirrhotic patients; to evaluate the real weight of HVPG in a multivariate analysis. METHODS: Multicentric observational prospective study. INCLUSION CRITERIA: All patients with liver cirrhosis with indication for surgical resection for hepatocellular carcinoma are considered eligible. Patients will be selected for surgery based on standard criteria of participating centers and on Child-Pugh score 0, A or B. EXCLUSION CRITERIA: Patients undergoing emergency surgery; inability to understand informed consent. Primary endpoint: Comparison of the predictive accuracy (evaluated as Area Under The Curve of the ROC curve, see statistics) of HVPG, ICG and Liver and Spleen Stiffness of Post-operative Hepatic Failure (PHLF, according to ISGLS). Secondary endpoints: - Predictive accuracy of HVPG, ICG-R15, LSM and SSM on postoperative morbidity at 90 days according to the classification of Clavien-Dindo and to the Comprehensive Complication Index (CCI), and on cirrhosis decompensation at 3 months after surgery.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• predictive accuracy of HVPG and ICG-r15 on PHLF

  90 days

Interventions

Hepatic venous-portal gradient (HVPG) measurement DIAGNOSTIC_TEST

preoperative evaluation of Hepatic venous-portal gradient (HVPG) and ICG-retention test

Also known as: ICG-retention test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cirrhotic patients with HCC undergoing liver resection

You may qualify if:

• All adult patients with liver cirrhosis with indication for surgical resection for hepatocellular carcinoma are considered eligible. Patients will be selected for surgery based on standard criteria of participating centers and on Child-Pugh score 0, A or B

You may not qualify if:

• Patients undergoing emergency surgery; inability to understand informed consent.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University Hospital

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Roberto I Troisi, Md, PhD

  Department of Clinical Medicine and Surgery, Federico II University of Naples

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto I Troisi, Md, PhD

CONTACT

+390817462776; roberto.troisi@unina.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor of Surgery

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 5, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: April 5, 2023

Record last verified: 2023-03

Locations

IT (1)