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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028608
Receipt No. R000032743
Scientific Title Efficacy and safety study of preoperative marking for undetectable hepatic tumor
Date of disclosure of the study information 2017/08/09
Last modified on 2019/02/09

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Basic information
Public title Efficacy and safety study of preoperative marking for undetectable hepatic tumor
Acronym Preoperative marking for undetectable hepatic tumor
Scientific Title Efficacy and safety study of preoperative marking for undetectable hepatic tumor
Scientific Title:Acronym Preoperative marking for undetectable hepatic tumor
Region
Japan

Condition
Condition hepatic tumor requiring surgical resection
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 For liver tumors that can be confirmed on images with a diameter of 20 mm or less, preoperative marking is performed, exploring the safety of marking and completion of resection by surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes After marking, CT, ultrasound marker and tumor visibility (visible / impossible)
Visibility (markable / impossible) of markers and tumor at hepatectomy
Percentage of completion of markers and tumor resection
Measurement of final marker and tumor distance
Key secondary outcomes Complications during marking
Surgery results
Postoperative liver dysfunction
Postoperative complication

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
Device,equipment
Interventions/Control_1 Percutaneous marking for liver tumor
Transcatheteratic marking for liver tumors
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. Patient scheduled for diagnosis for liver tumor.
2. Patient who is scheduled for hepatectomy for hepatic tumor.
3. Patient whose Performance Status (PS) of the Eastern Cooperative Oncology Group (ECOG) is 0 - 1.
4. Male or female aged 20 years or older at the time of acquiring consent (no outpatient or hospitalization is acceptable).
5. Patients who have obvious tumorous lesions in the liver due to various imaging tests such as CT and MRI. Although the number of tumors is not specified, only one tumor to be marked is 20 mm or less in diameter.
6. Patient who satisfies the following criteria in the blood test at the time of registration, and retains the functions of major organs (bone marrow, liver, kidney, lung, etc.).
A) Leukocyte count: 2,000 / mm 3 or more
B) Hemoglobin content: not less than 8.0 g / dl
C) Number of platelets: 50,000 / mm 3 or more
D) Total bilirubin: 3.0 mg / dl or less
E) eGFR: 60 ml / min / 1.73 m 3 or more (In case of falling below, decide on pretreatment and treatment in accordance with the provision of "Angiography examination IVR for patients with impaired renal function" in the hospital.
7. Patient who has sufficient judgment ability to understand the research contents and obtained written consent for participation of this study.
8. Patient who can withdraw anticoagulant on the day of marking.
Key exclusion criteria 1. Patients with severe (NYHA class III or more) ischemic heart disease.
2. Patient who complicated of severe liver cirrhosis (hepatopathy degree C).
3. Patients with dyspnea requiring oxygen administration due to interstitial pneumonia, pulmonary fibrosis and others.
4. Patients who are undergoing dialysis with chronic renal failure.
5. Patients currently suffering from duplicated cancer of active activity.
6. Patients who are judged to be difficult to participate in research due to psychosis or psychiatric symptoms.
7. Other patients who are deemed inappropriate for the research researcher or research sharing doctor to conduct this research.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Ohdan
Organization Hiroshima University Hospital
Division name Department of gastroenterological surgery
Zip code
Address 1-2-3, Kasumi, Hiroshima city, Japan
TEL 082-257-5222
Email hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shintaro Kuroda
Organization Hiroshima University Hospital
Division name Department of gastroenterological surgery
Zip code
Address 1-2-3, Kasumi, Hiroshima city, Japan
TEL 082-257-5222
Homepage URL
Email shintarokuroda@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Department of gastroenterological surgery
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 広島大学病院

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 09 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 08 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 19 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 09 Day
Last modified on
2019 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032743

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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