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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031208
Receipt No. 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 2020/08/09

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

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 Unpublished

Result
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

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
2020 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.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


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