Estimation of Functional Liver Reserve Using Cholinesterases

Hepatocellular Carcinoma Clinical Trial

Official title:

Estimation of Functional Liver Reserve in Patients With Hepatocellular Carcinoma in Cirrhosis: the Value of Preoperative Cholinesterases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883454
• Other study ID #: CHE-HCC
• Status: Completed
• Phase: N/A
• First received: April 16, 2009
• Last updated: April 16, 2009

Study information

• Verified date: April 2009
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Estimation of functional liver reserve in patients with hepatocellular carcinoma (HCC) in cirrhosis is of paramount importance to properly select candidates for surgical resection. Together with the value of bilirubin, the presence/absence of ascites and esophageal varices, and the rate of residual liver volume, which are our current parameters to measure functional liver reserve, the investigators sought to investigate the value of preoperative cholinesterases (CHE) in predict postoperative adverse outcome after hepatic resection for HCC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Total bilirubin < 2 mg/dl

2. No ascites

3. No esophageal varices, or esophageal varices eradicated by endoscopy

4. Liver volume:

• residual liver volume > or = 40% if total bilirubin < 1 mg/dl

• residual liver volume > or = 50% if total bilirubin between 1 and 1.5 mg/dl

• only limited resection if total bilirubin > 1.5 mg/dl

5. Portal vein embolization was selected in any case in whom RLV did not fit the previous requirements.

Exclusion Criteria:

1. Total bilirubin > 2 mg/dl

2. Refractory ascites

3. Esophageal varices

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cirrhosis
• Hepatocellular Carcinoma
• Liver Cirrhosis
• Liver Disease
• Liver Diseases
• Liver Neoplasm
• Liver Neoplasms

Locations

Country	Name	City	State
Italy	Liver Surgery Unit, Third Department of Surgery, University of MIlan, IRCCS Istituto Clinico Humanitas	Rozzano, Milan	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was to investigate the value of preoperative cholinesterases in predict postoperative adverse outcome after hepatic resection for hepatocellular carcinoma in cirrhosis.			No