UMIN-CTR Clinical Trial

Public title

Japanese Society of Hepato-Biliary-Pancreatic Surgery, Project 09 of Hepatic Surgery
National survey of surgical treatment for hepatocellular carcinoma associated with inferior vena cava invasion

Acronym

National survey of surgical treatment for hepatocellular carcinoma associated with inferior vena cava invasion

Scientific Title

Japanese Society of Hepato-Biliary-Pancreatic Surgery, Project 09 of Hepatic Surgery
National survey of surgical treatment for hepatocellular carcinoma associated with inferior vena cava invasion

Scientific Title:Acronym

National survey of surgical treatment for hepatocellular carcinoma associated with inferior vena cava invasion

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to collect the clinical data on liver resection for hepatocellular carcinoma (HCC) accompanied by tumor thrombus (TT) in the inferior vena cava (IVC) or right atrium (RA) in Japan as a multicenter study, to clarify the short- and long-term outcomes of surgical treatment for these patients, to determine which types of HCC with TT in the IVC or RA are amenable to surgery, and to develop recommendations and guidelines concerning HCC accompanied by TT in the IVC or RA.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Outcomes of this study consisted of demographic and preoperative information, type of TT, operative and postoperative information, pathologic information, and recurrence and survival data. The extent of portal vein tumor thrombus (PVTT) and bile duct tumor thrombus (BDTT) were categorized according to the Japanese staging system. In addition to providing the name of the surgical procedure for liver resection, information regarding the surgical method for TT in the IVC or RA, such as concomitant resection of the IVC wall, the use of graft, and the use of cardiopulmonary bypass (CPB) was also recorded. Curative-intent surgery (R0/1 resection) was defined as those with no residual tumor observed macroscopically at the end of the surgery, otherwise considered palliative (R2 resection). Liver failure, bile leakage, and postoperative hemorrhage were recorded using the definition of the International Study Group of Liver Surgery. Other complications were recorded according to the Clavien-Dindo classification. Surgery-related death (complications of grade V) was defined as the death of a patient before discharge.

Key secondary outcomes

Study type

Observational

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who underwent liver resection for HCC with TT in the IVC or RA. This includes cases of HCC with TT in the IVC or RA on pathological diagnosis, even though no TT in the IVC or RA was found in imaging studies before surgery.
2) Cases in which the diagnosis was made by one of the modalities of CT, US, or MRI.
3) Patients who underwent open or laparoscopic resection.
4) Patients and their family members have given full understanding and written consent for participation in clinical research by means of the hospital's comprehensive consent form.

Key exclusion criteria

1) Cases in which only medical treatment (transcatheter arterial chemoembolization, chemotherapy, etc.) was performed and liver resection was not performed.
2) Patients whose preoperative diagnosis was HCC, but the resected specimen showed other neoplastic lesions.
3) Other patients deemed inappropriate by the physician in charge.

Target sample size

150

Name of lead principal investigator

1st name	Kiyoshi
Middle name
Last name	Hasegawa

Organization

The University of Tokyo

Division name

Hepato-Biliary-Pancreatic Surgery Division

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

+81-3-5800-8779

Email

hasegawa-2su@h.u-tokyo.ac.jp

Name of contact person

1st name	Akihiko
Middle name
Last name	Ichida

Organization

The University of Tokyo

Division name

Hepato-Biliary-Pancreatic Surgery Division

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

+81-3-3815-5411

Homepage URL

Email

ichida-tky@umin.ac.jp

Institute

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name

Organization

The Japanese Society of Hepato-Biliary-Pancreatic Surgery

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

the Graduate School of Medicine and Faculty of Medicine, the University of Tokyo Research Ethics Committee

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

Tel

+81-3-3815-5411

Email

ethics@m.u-tokyo.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

徳島大学病院 消化器・移植外科　（徳島県）
信州大学　医学部・医学系研究科　外科学第一講座　（長野県）
財団法人厚生会　仙台厚生病院 消化器外科　（宮城県）
東北大学病院 消化器外科　（宮城県）
近畿大学病院　外科　（大阪府）
筑波大学附属病院　消化器外科　（茨城県）
京都大学医学部附属病院　肝胆膵・移植外科　（京都府）
宮崎大学医学部附属病院　外科学講座　（宮崎県）
熊本大学病院　消化器外科　（熊本県）
岡山済生会総合病院　外科　（岡山県）
大阪公立大学医学部附属病院　肝胆膵外科　（大阪府）
東京医科歯科大学医学部附属病院　肝胆膵外科　（東京都）
兵庫医科大学病院　肝胆膵外科　（兵庫県）
福島県立医科大学附属病院　肝胆膵・移植外科　（福島県）
新潟大学医歯学総合病院　消化器・一般外科　（新潟県）
藤田医科大学病院　総合消化器外科　（愛知県）
埼玉医科大学国際医療センター　肝胆膵外科　（埼玉県）
北海道大学病院　消化器外科Ⅰ　（北海道）
大阪市立総合医療センター　肝胆膵外科　（大阪府）
奈良県総合医療センター　消化器・肝胆膵外科　（奈良県）
大阪赤十字病院　消化器外科　（大阪府）
旭川医科大学 外科学講座 肝胆膵・移植外科学分野　（北海道）
東京大学医学部附属病院　肝胆膵外科　（東京都）

Date of disclosure of the study information

2022

Year

07

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

119

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

2017

Year

07

Month

14

Day

Date of IRB

2017

Year

07

Month

14

Day

Anticipated trial start date

2019

Year

10

Month

01

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

2022

Year

03

Month

31

Day

Date analysis concluded

2022

Year

07

Month

31

Day

Other related information

This retrospective, multi-center survey was planned as a project study of the Japanese Society of Hepato-Biliary-Pancreatic Surgery. This study was conducted with the approval of the ethics committee of the University of Tokyo (Review number: 11588) and of each participating institution. Among the 211 training institutions for highly advanced surgery registered by the Japanese Society of Hepato-Biliary-Pancreatic Surgery, 23 institutions with experience in surgery for HCC with TT in the IVC or RA participated in this study. Questionnaire sheets were sent to the participating institutions and the results of the replies were collected and analyzed at the Hepato-Biliary-Pancreatic Surgery Division, the University of Tokyo.

Registered date

2022

Year

07

Month

13

Day

Last modified on

2023

Year

01

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055122

Single case data URL

Value
https://center6.umin.ac.jp/ice/55122