UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study on safety of intraperitoneal access port system in intraperitoneal chemotherapy for gastric cancer
Acronym	Obeseravational study on safety of intraperitoneal access port system
Scientific Title	Prospective observational study on safety of intraperitoneal access port system in intraperitoneal chemotherapy for gastric cancer
Scientific Title:Acronym	Obeseravational study on safety of intraperitoneal access port system
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the safety of intraperitoneal access port system in intraperitoneal chemotherapy for gastric cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	adverse events
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)age ranged between 20 and 75 years old 2)histologically or cytologically proven peritoneal dissemination of gastric cancer 3)peritoneal dissemination with unresectable or recurrent gastric adenocarcinoma 4)performance status (Eastern Cooperative Oncology Group) of 0 to 2 5)an expected survival period of>3 months 6)adequate organ function 7)ability to oral intake 8)written infromed consent
Key exclusion criteria	1)no uncontrolled infection 2)no unsuitable body type for peritoenal accesss prot 3)no allergy for material of peritoneal access port 4)no unsuitalbe skin or subctaneous tissue trouble for peritoneal acesss port. 5)no severe complication 6)no uncontrolled pleural or cardiac effusion 7)no symptomatic brain metastasis 8)no other concurrent malignancies 9)no interstitial pneumoniae or pulmonary fibrosis 10)no pregnant 11)no massive ascites
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Fushida Sachio
Organization	Kanazawa University
Division name	Gastroenterlogic surgery
Zip code
Address	13-1 Takaramachi, Kanazawa 920-8641, Japan
TEL	011-81-76-265-2362
Email	fushida@staff.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Jun Kinoshita
Organization	Kanazawa University
Division name	Gastroenterlogic surgery
Zip code
Address	13-1 Takaramachi, Kanazawa 920-8641, Japan
TEL	011-81-76-265-2362
Homepage URL
Email	junkino0416@gmail.com

Sponsor
Institute	Kanazawa University
Institute
Department

Funding Source
Organization	Kanazawa university, Gastroenterlogic surgery
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	2016 Year 03 Month 07 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	Terminated
Date of protocol fixation	2014 Year 07 Month 24 Day
Date of IRB	2015 Year 03 Month 26 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We observe the frequency of adevere events associated with intraperitoneal acees port system.

Management information
Registered date	2016 Year 03 Month 07 Day
Last modified on	2021 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024647