UMIN-ICDS Clinical Trial

Public title

Is the anterior approach recommended for liver resection of hepatocellular carcinoma? A systematic review and meta-analysis.

Acronym

Anterior approach for HCC liver resection. A systematic review and meta-analysis.

Scientific Title

Is the anterior approach recommended for liver resection of hepatocellular carcinoma? A systematic review and meta-analysis.

Scientific Title:Acronym

Anterior approach for HCC liver resection. A systematic review and meta-analysis.

Region

Japan	Asia(except Japan)	North America
Australia	Europe

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Hepatocellular carcinoma (HCC) is the most common in the primary liver cancer. HCC tumors show an expanded growth and are sometimes found as huge tumors. Especially in the right hepatectomy case, the right liver is completely mobilized from the surrounding tissue, subsequently followed by liver resection and vascular outflow dissection. Although this technique has been considered as the conventional approach (CA), liver rotation during complete liver mobilization could cause massive bleeding, liver ischemia, hemodynamic instability due to compressing inferior vena cava, tumor rupture, and extrahepatic dissemination of tumor cells. To overcome these disadvantages, the anterior approach (AA) has been employed, which is preceded by initially vascular inflow control and liver resection without right liver mobilization. Liver hanging maneuver (LHM) is often used in conjunction with the AA, especially in the resection of huge HCC. The LHM, in which the liver is elevated during liver resection, aimed to reduce venous bleeding and the risk of vascular injury. Initially, AA and/or LHM were mainly used for right hepatectomy for huge tumors. However, due to their usefulness, they have been used in various hepatic resections. Several reports have shown that the AA is superior to the CA in short-term and long-term outcomes. However, there have been few studies with a high level of evidence.
The aim of this study was to evaluate the effectiveness of liver resection with the AA for HCC against that with the CA in the viewpoint of short-term and long-term outcomes, using meta-analytic methods.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary outcomes were in-hospital mortality and in-hospital morbidity as short-term outcomes, and disease-free survival (DFS) and overall survival (OS) as long-term outcomes.

Key secondary outcomes

The second outcomes were perioperative outcomes, including operative time, blood loss during surgery, need for blood transfusion, presence or absence of tumor cells at resection margins, and length of hospital stay.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Studies were included if they met the following criteria: The study design was an RCT or observational study, the study population was patients with HCC who underwent hepatectomy using AA or CA.

Key exclusion criteria

Case reports, case series, and non-English language studies were excluded.

Target sample size

Name of lead principal investigator

1st name	Takamichi
Middle name
Last name	Ishii

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Surgery

Zip code

606-8507

Address

54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto

TEL

81-75-751-3242

Email

taishii@kuhp.kyoto-u.ac.jp

Name of contact person

1st name	Takamichi
Middle name
Last name	Ishii

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Surgery

Zip code

606-8507

Address

54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto

TEL

81-75-751-3242

Homepage URL

Email

taishii@kuhp.kyoto-u.ac.jp

Institute

Graduate School of Medicine, Kyoto University
Department of Surgery
Takamichi Ishii

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto

Tel

81-75-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

07

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2023

Year

05

Month

31

Day

Date of IRB

2023

Year

05

Month

31

Day

Anticipated trial start date

2023

Year

05

Month

31

Day

Last follow-up date

2023

Year

08

Month

31

Day

Date of closure to data entry

2023

Year

08

Month

31

Day

Date trial data considered complete

2023

Year

10

Month

31

Day

Date analysis concluded

2023

Year

10

Month

31

Day

Other related information

The primary outcomes were in-hospital mortality and in-hospital morbidity as short-term outcomes, and disease-free survival (DFS) and overall survival (OS) as long-term outcomes. The second outcomes were perioperative outcomes, including operative time, blood loss during surgery, need for blood transfusion, presence or absence of tumor cells at resection margins, and length of hospital stay.
For continuous outcomes including operative time, blood loss during surgery, and length of hospital stay, standardized mean differences (SMDs) with corresponding standard deviation were extracted from each study. In cases that not describing mean and standard deviations, they were calculated from medians and ranges using the statistical methods by Hozo et al. For dichotomous outcomes including in-hospital morbidity, in-hospital mortality, need for blood transfusion, and presence or absence of tumor cells at resection margins, risk ratios (RRs) were calculated from the event number and the patient number. For disease-free survival, and overall survival, hazard ratios (HRs) were extracted from each study. For studies not describing HRs, the HR was calculated from a Kaplan-Meier curve of the matched population using a spreadsheet programmed to estimate the overall HR with a 95% confidence interval (CI) with an inverse variance-weighted average, which is provided by Tierney et al, based on standard statistical methods reported by Parmar et al. and Williamson et al.

Registered date

2023

Year

07

Month

21

Day

Last modified on

2023

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058980