UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028608 |
|---|---|
| Receipt number | 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 | 2022/02/12 10:18:13 |
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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 | Hideki |
| Middle name | |
| Last name | Ohdan |
Organization
Hiroshima University Hospital
Division name
Department of gastroenterological surgery
Zip code
734-8551
Address
1-2-3, Kasumi, Hiroshima city, Japan
TEL
082-257-5222
hohdan@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Kuroda |
Organization
Hiroshima University Hospital
Division name
Department of gastroenterological surgery
Zip code
734-8551
Address
1-2-3, Kasumi, Hiroshima city, Japan
TEL
082-257-5222
Homepage URL
shintarokuroda@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Department of gastroenterological surgery
Institute
Department
Personal name
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
Hiroshima University Hospital
Address
1-2-3, Kasumi, Hiroshima city, Japan
Tel
082-257-1725
protocol@cimr.hiroshima-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
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
19
Results
Preoperative marking for liver tumors could be performed without major adverse events.
Results date posted
| 2022 | Year | 02 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cases with liver tumors that are expected to be difficult to identify during surgery and require hepatectomy
Participant flow
Hepatectomy after preoperative marking
Adverse events
none
Outcome measures
Safety
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 07 | Day |
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
| 2022 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032743
