UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027871 |
|---|---|
| Receipt number | R000031910 |
| Scientific Title | The development of the transhepatic porto-systemic venous shunt(THPVS) for the portal hypertension |
| Date of disclosure of the study information | 2017/06/22 |
| Last modified on | 2019/06/26 06:59:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The development of the transhepatic porto-systemic venous shunt(THPVS) for the portal hypertension
Acronym
The development of the transhepatic porto-systemic venous shunt(THPVS) for the portal hypertension
Scientific Title
The development of the transhepatic porto-systemic venous shunt(THPVS) for the portal hypertension
Scientific Title:Acronym
The development of the transhepatic porto-systemic venous shunt(THPVS) for the portal hypertension
Region
| Japan |
Condition
Condition
portal hypertension
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of the newly-developed transheparic porto-venous shunt(THPVS) for the patients with the refractory ascites, pleural effusion or gastrointestinal hemorrhage due to portal hypertension.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
severe or unexpected adverse events within 4 weeks
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
1.Insert the basket snare catheter into the hepatic vein from internal jugular vein.
2.Puncture the portal vein and insert the basket snare catheter into the portal vein.
3.Puncture the two basket snares with Chiba needle with "gun sight" method.
4.Insert the guidewire from the needle into the portal vein.
5.Catch the guidewire with the snare catheter and pull the guidewire out of the body.
6.Retrieve the needle and catch the same guidewire with the snare catheter from the jugular vein.
7.Pull out the guidewire from the jugular vein.
8.Expand the intrahepatic pathway with the balloon catheter.
9.Put the metallic stentgraft through the intrahepatic pathway.
* Measure the portal pressure before and after the procedure.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.The patient with the refractory ascites or pleural effusion or gastrointestinal hemorrhage with portal hypertension.
2.Patients without thrombus in the intended hepatic vein or portal vein.
3.Patients without malignant tumor on the puncture line.
4.
1)white blood count:>=2000/mm3
2)platelet:>=50000/mm3
3)total serum bilirubin:<=3.0mg/dl
5.The MELD-Na score <= 17
Key exclusion criteria
1.Patients with unpuncturable organ on the puncture line on images.
2.Patients with obvious tendency of bleeding or coagulation disorder.
3.Patients with antiplatelet, thrombolysis or anticoagulation therapy.
4.Patients who are judged inappropriate by the principal investigator.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Sugihara |
Organization
Osaka general medical center
Division name
Division of diagnostic imaging
Zip code
537-8511
Address
3-1-56, Bandaihigashi, Sumiyoshi, Osaka
TEL
06-6692-1201
eiji.sja2@gmail.com
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Sugihara |
Organization
Osaka general medical center
Division name
Division of diagnostic imaging
Zip code
537-8511
Address
3-1-56, Bandaihigashi, Sumiyoshi, Osaka
TEL
06-6692-1201
Homepage URL
eiji.sja2@gmail.com
Sponsor or person
Institute
Osaka general medical center
Institute
Department
Personal name
Funding Source
Organization
no
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
Osaka general medical center
Address
3-1-56, Bandaihigashi, Sumiyoshi, Osaka
Tel
06-6692-1201
kenkyusien@gh.opho.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
| 2017 | Year | 06 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 22 | Day |
Last modified on
| 2019 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031910
