Hepatectomy With or Without the Thoraco-abdominal Approach | NCT03171428

Studies
Hepatectomy With or Without the Thoraco-abdominal Approach

NCT03171428

Sponsor

University of Milan

Status

Completed

Last Update Posted

Jun 1, 2017Actual

Enrollment

744Actual

Phase

Not provided

Conditions

Surgery
Liver Tumors
Hepatectomy
Liver Resection

Interventions

Hepatectomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2007Actual

Primary Completion Date

Dec 31, 2013Actual

Completion Date

Apr 1, 2015Actual

First Submitted Date

May 28, 2017

First Submission Date that Met QC Criteria

May 30, 2017

First Posted Date

May 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2017

Last Update Posted Date

Jun 1, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Guido Torzilli, Director of the Department of Hepatobiliary Surgery, University of MilanPrincipal Investigator

Lead Sponsor

University of MilanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

744Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hepatectomy	Procedure	Surgery for liver tumors is the removal of a part of the liver affected by a tumor.	AA TAA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006498	Hepatectomy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided