UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060927 |
|---|---|
| Receipt number | R000068530 |
| Scientific Title | A Prospective Study Exploring the Safety of Large-Volume Paracentesis in Patients with Malignant Ascites |
| Date of disclosure of the study information | 2026/03/13 |
| Last modified on | 2026/03/13 15:57:32 |
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Basic information
Public title
A Study to Evaluate the Safety of Removing a Large Amount of Ascites at One Time in Patients with Cancer
Acronym
Safety Study of Large-Volume Paracentesis
Scientific Title
A Prospective Study Exploring the Safety of Large-Volume Paracentesis in Patients with Malignant Ascites
Scientific Title:Acronym
Safety Study of Large-Volume Paracentesis for Malignant Ascites
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety of paracentesis procedures aiming for large-volume ascites drainage exceeding 4 liters in patients with malignant ascites.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of severe hypotension
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
Paracentesis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Diagnosed with unresectable, recurrent, or metastatic cancer
2 Age 18 years or older at registration
3 Abdominal distension due to ascites
4 Expected survival of 3 weeks or longer
5 Most recent blood test within 14 days prior to registration shows the following values:
a). Hemoglobin >= 6.0 g/dL
b). Platelet count >= 50,000/mm3
c). Creatinine level < 2.0 mg/dL
d). Total bilirubin level < 5.0 mg/dL
6 Written informed consent for study participation has been obtained from the subject.
Key exclusion criteria
1 Received new chemotherapy (including molecularly targeted drugs) or immunotherapy within the past 3 weeks
2 Has active systemic or intraperitoneal infection
3 Has a systolic blood pressure below 100 mmHg
4 Has a psychiatric disorder or psychiatric symptoms that are judged to make participation in the study difficult
5 Other patients deemed unsuitable for inclusion by the principal investigator (or sub-investigator)
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Kadono |
Organization
Osaka medical and pharmaceutical university hospital
Division name
Cancer Chemotherapy Center
Zip code
5698686
Address
2-7, Daigaku-cho, Takatsuki city, Osaka
TEL
0726831221
toru.kadono@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Kadono |
Organization
Osaka medical and pharmaceutical university hospital
Division name
Cancer Chemotherapy Center
Zip code
5698686
Address
2-7, Daigaku-cho, Takatsuki city, Osaka
TEL
0726831221
Homepage URL
toru.kadono@ompu.ac.jp
Sponsor or person
Institute
Osaka medical and pharmaceutical university
Institute
Department
Personal name
Toru Kadono
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka medical and pharmaceutical university
Address
2-7, Daigaku-cho, Takatsuki city, Osaka
Tel
0726831221
rinri@ompu.ac.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
| 2026 | Year | 03 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 13 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068530
