UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

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

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

一般向け試験名略称/Acronym

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

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

科学的試験名/Scientific Title

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

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

科学的試験名略称/Scientific Title:Acronym

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

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

試験実施地域/Region

日本/Japan	アジア（日本以外）/Asia(except Japan)
北米/North America	オセアニア/Australia
欧州/Europe

対象疾患名/Condition

日本語
肝細胞癌

英語
hepatocellular carcinoma

疾患区分1/Classification by specialty

消化器外科（肝・胆・膵）/Hepato-biliary-pancreatic surgery

疾患区分2/Classification by malignancy

悪性腫瘍/Malignancy

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
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.

英語
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.

目的2/Basic objectives2

安全性・有効性/Safety,Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語
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.

英語
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.

副次アウトカム評価項目/Key secondary outcomes

日本語
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.

英語
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.

試験の種類/Study type

その他・メタアナリシス等/Others,meta-analysis etc

基本デザイン/Basic design

ランダム化/Randomization

ランダム化の単位/Randomization unit

ブラインド化/Blinding

コントロール/Control

層別化/Stratification

動的割付/Dynamic allocation

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

群数/No. of arms

介入の目的/Purpose of intervention

介入の種類/Type of intervention

介入1/Interventions/Control_1

日本語

英語

介入2/Interventions/Control_2

日本語

英語

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

適用なし/Not applicable

年齢（上限）/Age-upper limit

適用なし/Not applicable

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語
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.

英語
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.

除外基準/Key exclusion criteria

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

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

目標参加者数/Target sample size

責任研究者/Name of lead principal investigator

日本語

名	隆道
ミドルネーム
姓	石井

英語

名	Takamichi
ミドルネーム
姓	Ishii

所属組織/Organization

日本語
京都大学医学研究科

英語
Graduate School of Medicine, Kyoto University

所属部署/Division name

日本語
肝胆膵・移植外科

英語
Department of Surgery

郵便番号/Zip code

606-8507

住所/Address

日本語
京都市左京区聖護院川原町54

英語
54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto

電話/TEL

81-75-751-3242

Email/Email

taishii@kuhp.kyoto-u.ac.jp

試験問い合わせ窓口担当者/Name of contact person

日本語

名	隆道
ミドルネーム
姓	石井

英語

名	Takamichi
ミドルネーム
姓	Ishii

組織名/Organization

日本語
京都大学医学研究科

英語
Graduate School of Medicine, Kyoto University

部署名/Division name

日本語
肝胆膵・移植外科

英語
Department of Surgery

郵便番号/Zip code

606-8507

住所/Address

日本語
京都市左京区聖護院川原町54

英語
54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto

電話/TEL

81-75-751-3242

試験のホームページURL/Homepage URL

Email/Email

taishii@kuhp.kyoto-u.ac.jp

機関名/Institute

日本語
その他

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

機関名/Institute
（機関選択不可の場合）

日本語
京都大学医学研究科

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
無し

英語
None

機関名/Organization
（機関選択不可の場合）

日本語
なし

組織名/Division

日本語

組織の区分/Category of Funding Organization

その他/Other

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語
京都大学大学院医学研究科・医学部及び医学部附属病院 医の倫理委員会

英語
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

住所/Address

日本語
京都市左京区聖護院川原町53

英語
53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto

電話/Tel

81-75-753-4680

Email/Email

ethcom@kuhp.kyoto-u.ac.jp

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2023

年

07

月

21

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

組み入れ参加者数/Number of participants that the trial has enrolled

主な結果/Results

日本語

英語

主な結果入力日/Results date posted

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2023

年

05

月

31

日

倫理委員会による承認日/Date of IRB

2023

年

05

月

31

日

登録・組入れ開始（予定）日/Anticipated trial start date

2023

年

05

月

31

日

フォロー終了(予定)日/Last follow-up date

2023

年

08

月

31

日

入力終了(予定)日/Date of closure to data entry

2023

年

08

月

31

日

データ固定（予定）日/Date trial data considered complete

2023

年

10

月

31

日

解析終了(予定)日/Date analysis concluded

2023

年

10

月

31

日

その他関連情報/Other related information

日本語
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.

英語
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.

登録日時/Registered date

2023

年

07

月

21

日

最終更新日/Last modified on

2023

年

11

月

08

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000058980

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