Estimation of Functional Liver Reserve Using Cholinesterases

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma; Cirrhosis; Liver Disease; Liver Neoplasm

• Study Type: Observational
• Enrollment (Actual): 181

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Milan, Italy, 20089
      • Liver Surgery Unit, Third Department of Surgery, University of MIlan, IRCCS Istituto Clinico Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The records of approximately 245 consecutive patients who were referred at our Unit because of HCC were reviewed. Among those, 191 (78%) were submitted to surgery, and 181 (74%) were resected. The patients excluded from surgery were addressed to symptomatic treatments because of advanced disease or impaired liver functional reserve, or to percutaneous ablation therapy according to our policy. Among resected patients, there were 145 (80%) men and 36 (20%) women, with median age of 67 years (range 36-87 years).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary outcome was to investigate the value of preoperative cholinesterases in predict postoperative adverse outcome after hepatic resection for hepatocellular carcinoma in cirrhosis.

Collaborators and Investigators

• Sponsor: University of Milan

Study record dates

Study Registration Dates

• First Submitted: April 16, 2009
• First Submitted That Met QC Criteria: April 16, 2009
• First Posted (Estimate): April 17, 2009

Study Record Updates

• Last Update Posted (Estimate): April 17, 2009
• Last Update Submitted That Met QC Criteria: April 16, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; cirrhosis; liver resection; liver tumor; tumor staging; liver disease staging
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Fibrosis; Carcinoma; Carcinoma, Hepatocellular; Liver Cirrhosis; Liver Neoplasms
• Other Study ID Numbers: CHE-HCC