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Estimation of Functional Liver Reserve Using Cholinesterases

This study has been completed.
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00883454
First received: April 16, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  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:

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:

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

ClinicalTrials.gov processed this record on May 22, 2013