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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027871
Receipt No. 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

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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
Email 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
Email eiji.sja2@gmail.com

Sponsor
Institute Osaka general medical center
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031910

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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