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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03171428
Other study ID # ThoraxForLiver
Secondary ID
Status Completed
Phase N/A
First received May 28, 2017
Last updated May 31, 2017
Start date January 1, 2007
Est. completion date April 1, 2015

Study information

Verified date May 2017
Source University of Milan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The performance of hepatectomy for liver tumors using the thoraco-abdominal approach (TAA) versus the abdominal approach (AA) is still debated.

The aim of the study is the analysis of the perioperative outcome of patients operated with or without the TAA for liver tumors.


Description:

The prospectively maintained database was queried. A 1:1 propensity score-matched analysis was applied. Among 744 patients, 246 undergoing hepatectomy with TAA and 246 undergoing hepatectomy with AA were compared. These patients were matched for baseline characteristics, underlying liver disease, comorbidity, tumor features, and extent of the resection. The rates of morbidity and mortality were the study endpoints.


Recruitment information / eligibility

Status Completed
Enrollment 744
Est. completion date April 1, 2015
Est. primary completion date December 31, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- First liver surgery;

- Any type of malignant liver tumor, including hepatocellular carcinoma on cirrhosis.

Exclusion Criteria:

- Previous history of liver surgery;

- Any type of benign liver tumor;

- Incomplete clinical, surgical, pathological or postoperative data;

- Patients treated with radiofrequency ablation alone or in combination with surgery were also excluded.

Study Design


Intervention

Procedure:
Hepatectomy
Surgery for liver tumors is the removal of a part of the liver affected by a tumor.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Milan

Outcome

Type Measure Description Time frame Safety issue
Primary Short-term outcome: Occurrence of postoperative complications or death after surgery Occurrence of postoperative complications or death after surgery Within 90-days after the operation
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