Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma

Cirrhosis Clinical Trial

Official title:

Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma: Validation on 336 Consecutive Hepatectomies.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056041
• Other study ID #: SafeSurgeryHCC
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: June 17, 2014
• Start date: January 2004

Study information

• Verified date: June 2014
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Selection criteria for safe hepatectomy for HCC are not well established. The aim of this study was the validation of the selection criteria for safe hepatectomy for hepatocellular carcinoma.

Description:

All consecutive patients submitted to hepatectomy for HCC based on the same preoperative selection criteria from our prospectively-maintained liver unit database. Such criteria included the value of bilirubin (BIL), the value of cholinesterases (CHE), the presence of ascites, the presence of esophageal varices, and the rate of residual liver volume.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• any patient with HCC submitted to hepatic resection at our Unit in the established frame time

Exclusion Criteria:

• any patient with missing data or lost at follow-up

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cirrhosis
• Hepatecellular Carcinoma
• Hepatectomy

Intervention

Procedure:
• Hepatectomy

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano, Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of surgery for HCC	The primary endpoint was the validation of our selection criteria for safe hepatectomy for HCC in regards to postoperative complications. The role of total bilirubin and cholinesterases was analzyed together with other clinical parameters.	90 days	No
Secondary	Score systems HCC	The secondary endpoint was the testing of the most common score systems for HCC, which are the CPT score, the MELD score, and the APRI score.	90 days	No