Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 16, 2009
April 16, 2009
Not Provided
Not Provided
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Estimation of Functional Liver Reserve Using Cholinesterases
Estimation of Functional Liver Reserve in Patients With Hepatocellular Carcinoma in Cirrhosis: the Value of Preoperative Cholinesterases

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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).

  • Hepatocellular Carcinoma
  • Cirrhosis
  • Liver Neoplasm
  • Liver Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
Not Provided
Not Provided

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00883454
CHE-HCC
No
Not Provided
University of Milan
Not Provided
Not Provided
University of Milan
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP