UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000262
Receipt number R000000312
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 2007/09/01
Last modified on 2005/10/10 14:55:50

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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

Gastrointestinal surgery

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


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


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


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


Homepage URL


Email



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


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

2007 Year 09 Month 01 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

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 07 Month 01 Day

Date trial data considered complete

2007 Year 07 Month 01 Day

Date analysis concluded

2007 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 10 Month 10 Day

Last modified on

2005 Year 10 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000312


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name