UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031029 |
|---|---|
| Receipt number | R000035435 |
| Scientific Title | Feasibility of a fast-track randomised controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with malignant ascites |
| Date of disclosure of the study information | 2018/02/19 |
| Last modified on | 2022/01/31 10:06:14 |
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Basic information
Public title
Feasibility of a fast-track randomised controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with malignant ascites
Acronym
Feasibility of a fast-track RCT of cell-free and concentrated ascites reinfusion therapy for patients with malignant ascites
Scientific Title
Feasibility of a fast-track randomised controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with malignant ascites
Scientific Title:Acronym
Feasibility of a fast-track RCT of cell-free and concentrated ascites reinfusion therapy for patients with malignant ascites
Region
| Japan |
Condition
Condition
malignant ascites
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the feasibility of conducting a fast-track trial of concentrated ascites reinfusion therapy(CART) for patients with malignant ascites.
Basic objectives2
Others
Basic objectives -Others
To estimate the efficacy and safety of CART for malignant ascites.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of patients whose time to next paracentesis are evaluable.
Key secondary outcomes
The period until ascites reaccumulation(e.g., Time to next paracentesis, paracentesis-free survival, abdominal distention relapse-free period, abdminal circumference rebound-free period, and paracentesis request-free period), intensity of ascites-related symptoms, and adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In this fast-track RCT, patients are randomised either to an intervention group, where they receive concentrated ascites reinfusion therapy(CART), or the control group, whrer they receive paracentesis only. After the first intervention, patients receive the opposite treatment when their ascites are reaccumulated.
Paracentesis:
Paracentesis is performed under sterile conditions and local anethesia. A 20 gauge aspiration needle is inserted into the peritoneal cavity in the left or right lower quadrant and ascitic fluid is removed by gravity in one to two hours. The removal volume of ascitic fluid is around 2000mL.
Interventions/Control_2
CART:
1) paracentesis
2) Removed ascitic fluid is filtrated with AHF-MOW (Asahi Kasei Medical, Tokyo, Japan), and is concentrated in about one-tenth with AHF-UP (Asahi Kasei Medical, Tokyo).
3) The filtered and concentrated ascetic fluid is reinfused into the patient via a
peripheral vein by 50-100mL/hour. To prevent fever up, acetaminophen 400mg is infused before ascites reinfusion.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Metastatic or locally advanced cancer patients diagnosed either pathologically or clinically.
2. Life expectancy >= 14 days
3. Hospitalized in Seirei Hospice
4. At least one symptomatic paracentesis within 3 weeks as well as an objectively verified, clinical need for a second paracentesis.
5. Refractory or resistant to chemotherapy, or standard chemotherapy is no longer feasible.
6. Patients who are fluent in Japanese.
7. Concent to this trial.
Key exclusion criteria
1. Patient who received chemotherapy, immunotherapy, hormonal therapy, or abdominal radiotherapy in the previous 28 days.
2. Patient who have systemic infections or abdominal infections.
3. Patient who generate fever >= 38 degree celsius.
4. Patient whose systolic blood pressure < 80mmHg.
5. Hemoglobine <6.0 mg/dL
Creatinine >= 2.0ug/dL
Total bilirubine >= 5.0mg/dL
6. Patient who have history of hepatic encephalopathy.
7. Patient who have cognitive inpairement.
8. Patient without any intravenous line.
9. Other reasons by which physicians judge they are ineligible.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naosuke |
| Middle name | |
| Last name | Yokomichi |
Organization
Seirei Mikatahara General Hospital
Division name
Seirei Hospice
Zip code
433-8558
Address
3453, Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka
TEL
053-436-1251
n-yokomichi@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Naosuke |
| Middle name | |
| Last name | Yokomichi |
Organization
Seirei Mikatahara General Hospital
Division name
Seirei Hospice
Zip code
433-8558
Address
3453, Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka
TEL
053-436-1251
Homepage URL
n-yokomichi@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Hospice, Seirei Mikatahara General Hospital
Institute
Department
Personal name
Funding Source
Organization
Sasagawa Memorial Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Mikatahara General Hospital
Address
3453, Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka
Tel
053-436-1251
mk-rinri@sis.seirei.or.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
聖隷三方原病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 19 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
20
Results
This study was an open-label, fast-track, randomized controlled, feasibility trial. Patients were randomly assigned 1:1 to a CART arm or control (simple paracentesis) arm. The feasibility endpoint was the percentage of patients who completed the study intervention.
Of 20 patients allocated, 18 patients (90%, 95% CI: 68.3-98.8) completed the study intervention.
A fast-track randomized controlled trial of CART for patients with malignant ascites is feasible.
Results date posted
| 2021 | Year | 08 | Month | 01 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Under review
Date of the first journal publication of results
Baseline Characteristics
The median age was 71.5, and 80% were female. All patients had an ECOG performance status of 3 or 4. The most frequent primary tumor site was the pancreas (25%), followed by the gastrointestine (20%), and liver and bile duct (15%). Massive liver metastasis existed in 30% of patients.
Participant flow
We screened 953 patients for eligibility. Of 61 patients with refractory malignant ascites, 21 patients were determined as eligible. Finally, 20 patients consented and were allocated
Adverse events
One patient in the CART arm developed Grade 1 fever.
Outcome measures
18 patients (90%, 95% CI: 68.3-98.8) completed the study intervention. Median paracentesis-free survivals were 5 days (95% CI: 2-6) in the CART arm, and 6 days (3-9) in the control arm. Median PRO-paracentesis-free survivals were 4 days (2-5) and 5 days (1-9), respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 19 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 28 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035435
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