UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026193
Receipt number R000029804
Scientific Title Observational study on the therapeutic effect of endoscopic stent placement for malignant gastroduodenal obstruction
Date of disclosure of the study information 2017/02/17
Last modified on 2021/02/20 10:15:45

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Basic information

Public title

Observational study on the therapeutic effect of endoscopic stent placement for malignant gastroduodenal obstruction

Acronym

DS study

Scientific Title

Observational study on the therapeutic effect of endoscopic stent placement for malignant gastroduodenal obstruction

Scientific Title:Acronym

DS study

Region

Japan


Condition

Condition

Malignant gastroduodenal obstruction

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of endoscopic stent placement on malignant gastroduodenal obstruction and predictive factors.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of predictive factors for stent treatment effect

Key secondary outcomes

Occurrence of stent malfunction and overall survival


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have organic stenosis or obstruction in the stomach or duodenum due to malignant tumors and cause impaired food passage. The primary organ of the tumor does not matter.

Key exclusion criteria

Patients who are stenotic or obstructed by esophagus or gastric cardia etc., and it is difficult to perform endoscopic stent placement. In addition, a patient whose research director or researcher judged inappropriate endoscopic stent placement surgery.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Shuichi
Middle name
Last name Kaneko

Organization

Kanazawa University Hospital

Division name

Department of Gastroenterology

Zip code

9208641

Address

13-1,Takara-machi,Kanazawa

TEL

076-265-2000

Email

skaneko@m-kanazawa.jp


Public contact

Name of contact person

1st name Hajime
Middle name
Last name Takatori

Organization

Kanazawa University Hospital

Division name

Department of Gastroenterology

Zip code

9208641

Address

13-1,Takara-machi,Kanazawa

TEL

076-265-2235

Homepage URL


Email

takatori@m-kanazawa.jp


Sponsor or person

Institute

Kanazawa University Hospital
Department of Gastroenterology

Institute

Department

Personal name



Funding Source

Organization

Kanazawa University Hospital
Department of Gastroenterology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kanazawa University Medical Ethics Review Committee

Address

13-1,Takara-machi,Kanazawa

Tel

0762652110

Email

crc.irb-knz@esct.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



Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 17 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

No longer recruiting

Date of protocol fixation

2016 Year 09 Month 26 Day

Date of IRB

2016 Year 09 Month 21 Day

Anticipated trial start date

2016 Year 10 Month 01 Day

Last follow-up date

2021 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Presence of ascites
Site and range of stenosis
Stent retention date
Successful completion of stent placement
Stent placement site
Number of stents
Type of stent (product name, diameter, length, presence or absence of cover)
Feeding situation (GOOSS score) and performance status (ECOG and KPS) 7 days before detention, detention, 7 days after detention , 14 days later


Management information

Registered date

2017 Year 02 Month 17 Day

Last modified on

2021 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029804


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name