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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024647


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name