UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017705 |
|---|---|
| Receipt number | R000020511 |
| Scientific Title | Multi institutional joint research of efficacy and safety of Transcatheter Arterial Embolization with Embosphere for Polycystic liever disease. |
| Date of disclosure of the study information | 2015/05/27 |
| Last modified on | 2018/05/28 13:25:27 |
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Basic information
Public title
Multi institutional joint research of efficacy and safety of Transcatheter Arterial Embolization with Embosphere for Polycystic liever disease.
Acronym
Efficacy of Embosifere for polycystic liver disease.
Scientific Title
Multi institutional joint research of efficacy and safety of Transcatheter Arterial Embolization with Embosphere for Polycystic liever disease.
Scientific Title:Acronym
Efficacy of Embosifere for polycystic liver disease.
Region
| Japan |
Condition
Condition
Polycystic liver disease or Autosomal dominant polycystic kidney disease
Classification by specialty
| Nephrology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of transcatheter arterial embolization with Embosphere® in polycysitc liver disease patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1 The volume reduction rate of the liver at six months after TAE
2 Change of abdominal fullness at six months after TAE
Key secondary outcomes
1 The volume reduction rate of the liver cysts at six months after TAE
2 Change in QOL score
3 Success rate of target vessel embolization
4 Improvement of nutritional status (serum albumin, hematocrit)
5 Improvement of portal hypertension (platelet)
6 Improvement of respiratory function
7 Reduction rate of maximum circumferential abdominal girth
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
TAE with NK939
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients between the ages of 20 to 80 years at the time of obtaining written consent
2) Patients who have been diagnosed with type 2 or type 3 polycystic liver by Gigot category with CT, MRI or Ultra Sound
3) Patients who scored more than 3 points of NRS twice between acquisition of written consent and registration.
4) Patients who scores 0, 1 or 2 for PS(ECOG Performance Status)
5) Patients to whom sufficient information have been provided and with his/her full understanding of the trial, written consent have been obtained
Key exclusion criteria
1) Patients with Active inflammatory disease (CRP over 2.0 mg/dl)
2) Patients with leukocyte count which exceeds institutional standards' upper limit
3) Patients with blood platelet count less than 50,000 /micro l
4) Patients with serum bilirubin concentration more than 3 mg/dl
5) Patients with AST/ALT which is higher than five times of the institutional standards' upper limit
6) Patient with glomerulus filtration (eGFR) less than 30 ml/min/1.73m 2.
7) Patients with fully closed portal vein.
8) Patients who has diagnosed with malignant tumor within 5 years from provisional registration
9) Patients with Renal Disease, Liver Disease and/or Heart Disease with unfavorable prognosis
10) Patients with history of iodine contrast agent hypersensitivity
11) Patients who have shown hyper sensitivity to ingredients of NK939 (acrylic polymers, gelatin)
12) Pleural effusion which requires invasive treatments
13) Ascites which requires invasive treatments
14) Patients with past history of transcatheter arterial embolization
15) Patients with past history of hepatectomy / puncture within 3 years from registration
16) Patients with concurrence of liver cyst and cyst kidney has occurred and adequate for kidney TAE (after dialysis introduction (blood, peritoneal) and self-volume of urine less than 500 ml/day). If the symptom remains after kidney TAE, the patients may be enrolled.
17) Patients who started Tolvaptan within 6 months from acquisition of written consent
18) Pregnant/lactating women. Fertile Women who are unable to practice contraception
19) Patients whom principal investigator or sub investigator have determined inadequate for the trial
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Saori Nishio |
Organization
Hokkaido University Hospital
Division name
Internal medicine II
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan060-8638
TEL
011-706-5916
saorin@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Miyakoshi |
Organization
Hokkaido University Hospital
Division name
Clinical Research and Medical Innovation Center
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Japan060-8638
TEL
011-706-7923
Homepage URL
mi_taka_1112@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Women's Medical University Hospital
Hospital attached to the Teikyo University medical department
Niigata University Medical & Dental Hospital
Osaka University Hospital
Juntendo Unversity Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 05 | Month | 27 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 21 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 27 | Day |
Last modified on
| 2018 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020511
