UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031910