UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Palliative effect of interaperitoneal administration of triamcinolone acetonide in patients with malignant peritonitis
Title of the study (Brief title)	Intraperotoneal administration of Kenacolt
Region	Japan

Condition
Condition	refractory patients with malignant peritonitis
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of intraperitoneal administration of triamcinolone acetonide
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to the next abdominal puncture
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	Medicine
Interventions/Control_1	Triamcinolone acetonide
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	20 years-old <=
Age-upper limit	99 years-old >
Gender	Male and Female
Key inclusion criteria	1. Refractory malignant peritonitis required the abdoninal puncture over twice per two weeks 2. not indicated patinets with chemotherapy 3. life ecpectancy less than 6 months 4. more than 20 years old 5. Written informed consent
Key exclusion criteria	1. bloody ascitis 2. infectious peritonitis 3. in controlled diabetes mellitus (HbA1c; more than 8.5%) 4. Pregnant or breast feeding woman 5. Not available for follow-up assesments or unable to comply with study
Target sample size	27

Research contact person
Name of lead principal investigator	Koji Takeda
Organization	Osaka City General Hospital
Division name	Dept. of Clinical Oncology
Address	2-13-22, Miyakojimahondohri, Miyakojima-ku, Osaka, Japan
TEL	06-6929-1221
Email	ko-takeda@med.osakacity-hp.or.jp

Public contact
Name of contact person	Hirofumi Katayama
Organization	Osaka City General Hospital
Division name	Dept. of palliative amedicine
Address	2-13-22, Miyakojimahondohri, Miyakojima-ku, Osaka, Japan
TEL	06-6929-1221
Homepage URL
Email	ko-takeda@med.osakacity-hp.or.jp

Sponsor
Institute	Koji Takeda
Institute
Department

Funding Source
Organization	Dept.of Clincial Oncology, Osaka City General Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 03 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 02 Month 28 Day
Anticipated trial start date	2013 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	No patients was entered in this study.
Other related information

Management information
Registered date	2013 Year 03 Month 13 Day
Last modified on	2017 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011981