Estimation of Functional Liver Reserve Using Cholinesterases

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00883454

First Posted: April 17, 2009

Last Update Posted: April 17, 2009

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Information provided by:

University of Milan

Purpose

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.

Condition
Hepatocellular Carcinoma Cirrhosis Liver Neoplasm Liver Disease


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Estimation of Functional Liver Reserve in Patients With Hepatocellular Carcinoma in Cirrhosis: the Value of Preoperative Cholinesterases

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Further study details as provided by University of Milan:

Primary Outcome Measures:

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


Enrollment:	181

Eligibility

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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).

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Total bilirubin > 2 mg/dl
Refractory ascites
Esophageal varices

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883454

Locations


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

Sponsors and Collaborators

University of Milan

More Information


ClinicalTrials.gov Identifier:	NCT00883454 History of Changes
Other Study ID Numbers:	CHE-HCC
First Submitted:	April 16, 2009
First Posted:	April 17, 2009
Last Update Posted:	April 17, 2009
Last Verified:	April 2009

Keywords provided by University of Milan:


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

Additional relevant MeSH terms:


Carcinoma Carcinoma, Hepatocellular Fibrosis Liver Cirrhosis Liver Diseases Liver Neoplasms Neoplasms, Glandular and Epithelial	Neoplasms by Histologic Type Neoplasms Adenocarcinoma Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Pathologic Processes

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