Estimation of Functional Liver Reserve Using Cholinesterases

NCT00883454 | Completed

• 1 other identifier: CHE-HCC
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Cirrhosis; Liver Neoplasm; Liver Disease

Keywords

hepatocellular carcinoma; liver tumor; cirrhosis; liver resection; tumor staging; liver disease staging

Outcome Measures

Primary Outcomes (1)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Total bilirubin \< 2 mg/dl
• No ascites
• No esophageal varices, or esophageal varices eradicated by endoscopy
• 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
• Portal vein embolization was selected in any case in whom RLV did not fit the previous requirements.

You may not qualify if:

• Total bilirubin \> 2 mg/dl
• Refractory ascites
• Esophageal varices

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Liver Surgery Unit, Third Department of Surgery, University of MIlan, IRCCS Istituto Clinico Humanitas

Rozzano, Milan, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Fibrosis; Liver Neoplasms; Liver Diseases

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 17, 2009
• Last Updated: April 17, 2009

Record last verified: 2009-04

Locations

IT (1)