Estimation of Functional Liver Reserve Using Cholinesterases - Full Text View

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 Liver Cancer Liver Diseases

Genetic and Rare Diseases Information Center resources: Liver Cancer

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. [ Designated as safety issue: No ]


Enrollment:	181

Eligibility


Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


ClinicalTrials.gov Identifier:	NCT00883454 History of Changes
Other Study ID Numbers:	CHE-HCC
Study First Received:	April 16, 2009
Last Updated:	April 16, 2009
Health Authority:	Italy: Ministry of Health

Keywords provided by University of Milan:


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

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 03, 2015