Hepatectomy With or Without the Thoraco-abdominal Approach

Hepatectomy With or Without the Thoraco-abdominal Approach: Impact on Perioperative Outcome

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.

Study Overview

• Status: Completed
• Conditions: Hepatectomy; Surgery; Liver Tumors; Liver Resection
• Intervention / Treatment: Procedure: Hepatectomy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 744

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients affected by liver tumors scheduled for hepatectomy at our center.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAA; Thoraco-Abdominal Approach: those patients with liver tumors operated with the thoracic-abdominal approach	Procedure: Hepatectomy; Surgery for liver tumors is the removal of a part of the liver affected by a tumor.; Other Names: hepatic resection; liver resection; liver surgery
AA; Abdominal Approach: those patients with liver tumors operated with the abdominal approach (without the thoracotomy)	Procedure: Hepatectomy; Surgery for liver tumors is the removal of a part of the liver affected by a tumor.; Other Names: hepatic resection; liver resection; liver surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Milan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Actual): December 31, 2013
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 28, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: ThoraxForLiver

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No