NCT03171428

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
744

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

7 years

First QC Date

May 28, 2017

Last Update Submit

May 31, 2017

Conditions

SurgeryLiver TumorsHepatectomyLiver Resection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

TAA

Thoraco-Abdominal Approach: those patients with liver tumors operated with the thoracic-abdominal approach

Procedure: Hepatectomy

AA

Abdominal Approach: those patients with liver tumors operated with the abdominal approach (without the thoracotomy)

Procedure: Hepatectomy

Interventions

HepatectomyPROCEDURE

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

Also known as: hepatic resection; liver resection; liver surgery
AATAA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • First liver surgery;
  • Any type of malignant liver tumor, including hepatocellular carcinoma on cirrhosis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Hepatobiliary Surgery

Study Record Dates

First Submitted

May 28, 2017

First Posted

May 31, 2017

Study Start

January 1, 2007

Primary Completion

December 31, 2013

Study Completion

April 1, 2015

Last Updated

June 1, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share