We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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:

  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
  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