UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000040 |
|---|---|
| Receipt number | 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 13:20:44 |
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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 |
| Obstetrics 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
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/
jivrosgoffice@ml.res.ncc.go.jp
Sponsor or person
Institute
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000080
