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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000040
Receipt No. R000000080
Scientific Title A phase I/II study of transjugular-transhepatic peritoneo-venous shunting for malignant ascites (JIVROSG-0201)
Date of disclosure of the study information 2005/08/05
Last modified on 2012/09/21

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Basic information
Public title A phase I/II study of transjugular-transhepatic peritoneo-venous shunting for malignant ascites (JIVROSG-0201)
Acronym Transjugular-transhepatic peritoneo-venous shunting for malignant ascites(JIVROSG-0201)
Scientific Title A phase I/II study of transjugular-transhepatic peritoneo-venous shunting for malignant ascites (JIVROSG-0201)
Scientific Title:Acronym Transjugular-transhepatic peritoneo-venous shunting for malignant ascites(JIVROSG-0201)
Region
Japan

Condition
Condition Cancer-related refractory ascites
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Breast surgery
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of transjugular-transhepatic peritoneo-venous shunting in patients with cancer-related refractory ascites.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Adverse events
Key secondary outcomes Improvement of symptom, decrease of ascites and body weight, elimination of diuretics.

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 Under local anesthesia, a route from jugular vein reaching to the abdominal cavity through the superior vena cava, hepatic vein and liver parenchymal tissue is made, and then, a transjugular-transhepatic peritoneo-venous shunting catheter is placed.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Symptomatic refractory ascites adversely influencing on QOL.
2) Patent superior vena cava and hepatic vein confirmed by CT.
3) Serous ascites.
4) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
6) Expected survival over 4 weeks.
7) Written informed consent.
Key exclusion criteria 1) Controllable ascites by standard anti-cancer therapies.
2) Intracavitary administration of anti-cancer agent is scheduled.
3) Controllable ascites by vascular interventions.
4) No symptom due to ascites.
5) Ascites due to malignatnt mesothelioma, mucin-producting tumor, pseudomyxoma.
6) Bloody, chylous or cloudy ascites.
7) Tumor or dilated intestine along the planned route for catheterization.
8) Active infection.
9) Untreated esophageal varices with red-color sign.
10) Active bleeding from upper digestive tract.
11) Post hepatic lobectomy.
12) Cardiac pacemaker.
13) Pregnancy.
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuaki Arai
Organization National Cancer Center Hospital
Division name Division of Diagnostic Radiology
Zip code
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuaki Arai
Organization JIVROSG, Coordinating Office
Division name Division of Diagnostic Radiology, National Cancer Center Hospital
Zip code
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL 03-3542-2511
Homepage URL http://jivrosg.umin.jp/
Email jivrosgoffice@ml.res.ncc.go.jp

Sponsor
Institute Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2005 Year 08 Month 05 Day

Related information
URL releasing protocol http://jivrosg.umin.jp/
Publication of results Unpublished

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/21512054
Number of participants that the trial has enrolled
Results
Procedures were completed in all 33 cancer patients (PS 0 in 1, 1 in 11, 2 in 6 and 3 in 15). The right jugular vein was used in 28 pts for the access route, and the right HV was used in 32 pts for perforating route. The pressure gradient between SVC and AC was 17+/-6 cmH2O (mean +/- S.D). The required time was 53+/-30 min (mean +/- S.D). 8 patients died of primary disease progression within 30 days after the procedure. As the procedure related major adverse reaction (>/=Grade 2), decrease of serum albumin, decrease of hemoglobin, appearance of pleural effusion, skin inflammation around the catheter insertion site, congestive cardiac failure, reactive fever were observed in 7,6,3,3,1 and 1 case, respectively. Response rate was 67% (50-80% in 95% CI) (SE in 11, ME in 11 and NE in 11). In 7 among the responded pts, re-increase of ascites occurred over 10 days after the procedure presumed caused by fibrin sheath formation around the TTPVS catheter.   
Conclusion
Newly developed TTPVS is safe and feasible procedure. And it may potentially replace the conventional shunt using subcutaneous lager tube to manage RA in cancer pts because of its lower invasion and efficacy. However, to achieve the better clinical outcome, the improvement of TTPVS catheter will be required.
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
2002 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2003 Year 02 Month 01 Day
Last follow-up date
2007 Year 06 Month 01 Day
Date of closure to data entry
2007 Year 09 Month 01 Day
Date trial data considered complete
2007 Year 09 Month 01 Day
Date analysis concluded
2007 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 05 Day
Last modified on
2012 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000080

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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