UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021370 |
|---|---|
| Receipt number | R000024647 |
| Scientific Title | Prospective observational study on safety of intraperitoneal access port system in intraperitoneal chemotherapy for gastric cancer |
| Date of disclosure of the study information | 2016/03/07 |
| Last modified on | 2021/03/12 09:20:17 |
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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
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
junkino0416@gmail.com
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024647
