Estimation of Functional Liver Reserve Using Cholinesterases

Completed

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

• Registration Number: NCT00883454
• Lead Sponsor: University of Milan

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-04
• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-16
• Last Update Submitted: 2009-04-16
• Study First Posted: 2009-04-17
• Last Update Posted: 2009-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Liver Surgery Unit, Third Department of Surgery, University of MIlan, IRCCS Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Milan, Italy