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OpenTrials
Completed

NCT Number: NCT02056041

Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma

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.

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Key information

Conditions

Hepatectomy Cirrhosis Fibrosis Hepatecellular Carcinoma Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hepatectomy

Procedure

Other names: Liver surgery, Liver resection, Hepatic resection

Primary outcomes

  1. Safety of surgery for HCC

    Time frame: 90 days

    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.

Secondary outcomes

  1. Score systems HCC

    Time frame: 90 days

    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.

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2013
First posted
Feb 5, 2014
Registry last updated
Jun 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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