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
肝細胞癌切除患者におけるサルコペニアの意義：欧州と日本の比較

英語
Impact of sarcopenia on clinical outcomes for patients with resected hepatocellular carcinoma: A retrospective comparison of eastern and western cohorts

一般向け試験名略称/Acronym

日本語
肝細胞癌切除患者におけるサルコペニアの意義：欧州と日本の比較

英語
Impact of sarcopenia on clinical outcomes for patients with resected hepatocellular carcinoma: A retrospective comparison of eastern and western cohorts

科学的試験名/Scientific Title

日本語
肝細胞癌切除患者におけるサルコペニアの意義：欧州と日本の比較

英語
Impact of sarcopenia on clinical outcomes for patients with resected hepatocellular carcinoma: A retrospective comparison of eastern and western cohorts

科学的試験名略称/Scientific Title:Acronym

日本語
肝細胞癌切除患者におけるサルコペニアの意義：欧州と日本の比較

英語
Impact of sarcopenia on clinical outcomes for patients with resected hepatocellular carcinoma: A retrospective comparison of eastern and western cohorts

試験実施地域/Region

日本/Japan	欧州/Europe

対象疾患名/Condition

日本語
肝細胞癌切除患者

英語
Patients who underwent liver resection for 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
本研究は欧米（オランダ）と日本（岡山大学）において肝細胞癌に対して手術を受けた患者間で、骨格筋量（サルコペニア）、予後予測因子と短期・長期予後との関連性を後方視的に検討することを目的としている。

英語
Muscle mass, as a reflection thereof, can be objectively measured. However, the role of east-west differences remains unclear. Therefore, we compared the impact of muscle mass on clinical outcomes after liver resection for HCC in a Dutch and Japanese setting and evaluated the predictive performance of different cut-off values for sarcopenia.

目的2/Basic objectives2

安全性/Safety

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
全生存率OS

英語
The primary outcome was overall survival (OS), defined as the time in days between the date of resection and the date of death or last follow-up.

副次アウトカム評価項目/Key secondary outcomes

日本語
術後無病生存率DFS、術後入院期間、重篤な合併症率、90日死亡率

英語
We investigated short-term outcome measures: recurrence free survival (RFS), length of hospital stay, complications with Clavien-Dindo grade (CD) > 2, and 90-day mortality.

試験の種類/Study type

観察/Observational

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

20

歳/years-old

以上/<=

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
2000年から2020年の間にエラスムスMC（オランダ）と岡山大学病院（日本）において肝細胞癌に対して肝切除術を受けた患者。

英語
All consecutive patients that had HCC and received curative liver resection at Erasmus MC, Netherlands, and Okayama University Hospital, Japan, in the period between January 2000 and January 2020 were included.

除外基準/Key exclusion criteria

日本語
術前3か月前にCTにて筋肉量を測定できない患者は除外。

英語
Patients were excluded if: HCC was not confirmed upon histopathological examination or if no preoperative computed tomography (CT) scan was available within three months prior to the resection.

目標参加者数/Target sample size

700

責任研究者/Name of lead principal investigator

日本語

名	弘誠
ミドルネーム
姓	高木

英語

名	Kosei
ミドルネーム
姓	Takagi

所属組織/Organization

日本語
岡山大学病院

英語
Okayama University Hospital

所属部署/Division name

日本語
消化器外科学

英語
Department of Gastroenterological Surgery

郵便番号/Zip code

700-8558

住所/Address

日本語
岡山市北区鹿田町2-5-1

英語
2-5-1 Shikata-cho, Kita-ku, Okayama

電話/TEL

+81-86-223-7151

Email/Email

kotakagi15@gmail.com

試験問い合わせ窓口担当者/Name of contact person

日本語

名	弘誠
ミドルネーム
姓	高木

英語

名	Kosei
ミドルネーム
姓	Takagi

組織名/Organization

日本語
岡山大学病院

英語
Okayama University Hospital

部署名/Division name

日本語
消化器外科学

英語
Department of Gastroenterological Surgery

郵便番号/Zip code

700-8558

住所/Address

日本語
岡山市北区鹿田町2-5-1

英語
2-5-1 Shikata-cho, Kita-ku, Okayama

電話/TEL

+81-86-223-7151

試験のホームページURL/Homepage URL

Email/Email

kotakagi15@gmail.com

機関名/Institute

日本語
その他

英語
Okayama University Hospital

機関名/Institute
（機関選択不可の場合）

日本語
Okayama University Hospital

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
Not applicable.

機関名/Organization
（機関選択不可の場合）

日本語
Okayama University Hospital

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
岡山大学病院

英語
Okayama University Hospital

住所/Address

日本語
岡山市北区鹿田町2-5-1

英語
2-5-1 Shikata-cho, Kita-ku, Okayama

電話/Tel

+81-86-223-7151

Email/Email

kotakagi15@gmail.com

他機関から発行された試験ID/Secondary IDs

はい/YES

試験ID1/Study ID_1

MEC-2018-1544

ID発行機関1/Org. issuing International ID_1

日本語
Medical Ethics Committee of Erasmus MC

英語
Medical Ethics Committee of Erasmus MC

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

01

月

16

日

プロトコル掲載URL/URL releasing protocol

https://journals.lww.com/international-journal-of-surgery/pages/articleviewer.aspx?year=2023&issue=0

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

https://journals.lww.com/international-journal-of-surgery/pages/articleviewer.aspx?year=2023&issue=0

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

700

主な結果/Results

日本語
The predictive performance of sarcopenia for both short-term and long-term outcomes was higher in JP compared to NL (maximum C-index: 0.58 vs. 0.55, respectively). However, differences between cutoff values were small. For the association between sarcopenia and OS, a strong association was found in JP [hazard ratio (HR) 2.00, 95% CI [1.230-3.08], P =0.002], where this was not found in NL (0.76 [0.42-1.36], P =0.351).

英語
The predictive performance of sarcopenia for both short-term and long-term outcomes was higher in JP compared to NL (maximum C-index: 0.58 vs. 0.55, respectively). However, differences between cutoff values were small. For the association between sarcopenia and OS, a strong association was found in JP [hazard ratio (HR) 2.00, 95% CI [1.230-3.08], P =0.002], where this was not found in NL (0.76 [0.42-1.36], P =0.351).

主な結果入力日/Results date posted

2024

年

01

月

06

日

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
In this multicenter retrospective cohort study, patients with HCC undergoing liver resection were included.

英語
In this multicenter retrospective cohort study, patients with HCC undergoing liver resection were included.

参加者の流れ/Participant flow

日本語
In this multicenter retrospective cohort study, patients with HCC undergoing liver resection were included.

英語
In this multicenter retrospective cohort study, patients with HCC undergoing liver resection were included.

有害事象/Adverse events

日本語
Demographics differed between NL and JP. Gender, age, and body mass index were associated with SMI. Significant effect modification between NL and JP was found for BMI. The predictive performance of sarcopenia for both short-term and long-term outcomes was higher in JP compared to NL (maximum C-index: 0.58 vs. 0.55, respectively). However, differences between cutoff values were small. For the association between sarcopenia and OS, a strong association was found in JP [hazard ratio (HR) 2.00, 95% CI [1.230-3.08], P =0.002], where this was not found in NL (0.76 [0.42-1.36], P =0.351). The interaction term confirmed that this difference was significant (HR 0.37, 95% CI [0.19-0.73], P =0.005).

英語
Demographics differed between NL and JP. Gender, age, and body mass index were associated with SMI. Significant effect modification between NL and JP was found for BMI. The predictive performance of sarcopenia for both short-term and long-term outcomes was higher in JP compared to NL (maximum C-index: 0.58 vs. 0.55, respectively). However, differences between cutoff values were small. For the association between sarcopenia and OS, a strong association was found in JP [hazard ratio (HR) 2.00, 95% CI [1.230-3.08], P =0.002], where this was not found in NL (0.76 [0.42-1.36], P =0.351). The interaction term confirmed that this difference was significant (HR 0.37, 95% CI [0.19-0.73], P =0.005).

評価項目/Outcome measures

日本語
The skeletal muscle mass index (SMI) was determined on computed tomography scans obtained within 3 months before surgery. The primary outcome measure was overall survival (OS). Secondary outcome measures were: 90-day mortality, severe complications, length of stay, and recurrence-free survival. The predictive performance of several sarcopenia cutoff values was studied using the concordance index (C-index) and area under the curve. Interaction terms were used to study the geographic effect modification of muscle mass.

英語
The skeletal muscle mass index (SMI) was determined on computed tomography scans obtained within 3 months before surgery. The primary outcome measure was overall survival (OS). Secondary outcome measures were: 90-day mortality, severe complications, length of stay, and recurrence-free survival. The predictive performance of several sarcopenia cutoff values was studied using the concordance index (C-index) and area under the curve. Interaction terms were used to study the geographic effect modification of muscle mass.

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

参加者募集終了‐試験継続中/No longer recruiting

プロトコル確定日/Date of protocol fixation

2018

年

10

月

11

日

倫理委員会による承認日/Date of IRB

2018

年

10

月

11

日

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

2018

年

11

月

01

日

フォロー終了(予定)日/Last follow-up date

2022

年

12

月

31

日

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

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

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語
N/A

英語
N/A

登録日時/Registered date

2023

年

01

月

05

日

最終更新日/Last modified on

2024

年

01

月

06

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=R000056915

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056915