UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031208
Receipt number R000035637
Scientific Title Phase I/II trial of preoperative hepatic vein embolization to increase future remnant liver volume before hepatectomy.
Date of disclosure of the study information 2018/02/15
Last modified on 2024/01/19 12:44:15

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Basic information

Public title

Phase I/II trial of preoperative hepatic vein embolization to increase future remnant liver volume before hepatectomy.

Acronym

Phase I/II trial of hepatic vein embolization to increase future remnant liver volume.

Scientific Title

Phase I/II trial of preoperative hepatic vein embolization to increase future remnant liver volume before hepatectomy.

Scientific Title:Acronym

Phase I/II trial of hepatic vein embolization to increase future remnant liver volume.

Region

Japan


Condition

Condition

Malignant hepatobiliary tumor

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of hepatic vein embolization (HVE) combined with preoperative PTPE and clinical usefulness of whether future liver remnant volume increase can be obtained by HVE.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Proportion of complications after hepatic vein embolization(Phase I).
Future liver remnant volume after hepatic vein embolization, and functional remnant liver volume(Phase II).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

hepatic vein embolization

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients scheduled for hepatectomy in cases suspected of malignant tumor since January 2018
2) Patients over 20 years old
3) Patients for whom consent is documented for participation in this study
4) Patients who determined that the remnant liver volume is not sufficient after hepatectomy
5) Patients who underwent portal vein embolization

Key exclusion criteria

1) Patients whose liver function and general condition deteriorated after portal vein embolization (PTPE), and hepatic vein embolization was considered difficult to perform
2) Other patients judged unsuitable as subjects by doctor's judgment

Target sample size

21


Research contact person

Name of lead principal investigator

1st name Ken
Middle name
Last name Shirabe

Organization

Gunma University Hospital

Division name

Department of Hepatobiliary and Pancreatic Surgery, Integrative center of general surgery

Zip code

371-8511

Address

3-39-15 Showa-machi, Maebashi, Gunma 371-8511, JAPAN

TEL

027-220-8227

Email

kshirabe@gunma-u.ac.jp


Public contact

Name of contact person

1st name Kenichiro
Middle name
Last name Araki

Organization

Gunma University Hospital

Division name

Department of Hepatobiliary and Pancreatic Surgery, Integrative center of general surgery

Zip code

371-8511

Address

3-39-15 Showa-machi, Maebashi, Gunma 371-8511, JAPAN

TEL

027-220-8227

Homepage URL


Email

karaki@gunma-u.ac.jp


Sponsor or person

Institute

Department of Hepatobiliary and Pancreatic Surgery, Integrative center of general surgery, Gunma University

Institute

Department

Personal name



Funding Source

Organization

Department of Hepatobiliary and Pancreatic Surgery, Integrative center of general surgery, Gunma University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gunma University Hospital Clinical Research Review Board

Address

3-39-15 Showa-machi, Maebashi city, GUNMA

Tel

027-220-7111

Email

irb-jimukk-ciru@ml.gunma-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 15 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

12 patients were registered.
The results of the Phase I/II study were reported in a article as shown below.

J Hepatobiliary Pancreat Sci. 2023 Jan;30(1):91-101.
doi: 10.1002/jhbp.1207. Epub 2022 Jul 6.
First published: 23 June 2022
https://doi.org/10.1002/jhbp.1207

Results date posted

2024 Year 01 Month 19 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 07 Month 23 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2017 Year 12 Month 27 Day

Date of IRB

2017 Year 12 Month 28 Day

Anticipated trial start date

2018 Year 01 Month 04 Day

Last follow-up date

2027 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 08 Day

Last modified on

2024 Year 01 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035637


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name