UMIN-CTR Clinical Trial

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
Email	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
Email	n-yokomichi@sis.seirei.or.jp

Sponsor
Institute	Seirei Hospice, Seirei Mikatahara General Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035435