UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028783
Receipt number R000032941
Scientific Title Efficacy and safety of duodenal stent in patients with gastric outlet obstruction: A multicenter prospective analysis
Date of disclosure of the study information 2017/08/24
Last modified on 2020/02/24 00:11:08

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Basic information

Public title

Efficacy and safety of duodenal stent in patients with gastric outlet obstruction: A multicenter prospective analysis

Acronym

Efficacy and safety of duodenal stent

Scientific Title

Efficacy and safety of duodenal stent in patients with gastric outlet obstruction: A multicenter prospective analysis

Scientific Title:Acronym

Efficacy and safety of duodenal stent

Region

Japan


Condition

Condition

Gastric outlet obstruction due to malignancy

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of duodenal stent for malignant gastric outlet obstruction

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficacy

Key secondary outcomes

Technical success rate

Safety


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

1. Gastric outlet obstruction due to malignancy
2. Written informed concent of the print.

Key exclusion criteria

1. Case with significantly poor general condition
2. Decision of unsuitableness by principal investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kazuya
Middle name
Last name azuya Sugimori

Organization

Yokohama City University Medical Center

Division name

Gastroenterological Center

Zip code

232-0024

Address

Urafune-cho 4-57, Minami-ku, Yokohama, Kanagawa, 232-0024,Japan

TEL

045-261-5656

Email

sugimori@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Haruo
Middle name
Last name Miwa

Organization

Yokohama City University Medical Center

Division name

Gastroenterological Center

Zip code

232-0024

Address

Urafune-cho 4-57, Minami-ku, Yokohama, Kanagawa, 232-0024,Japan

TEL

045-261-5656

Homepage URL


Email

miwa@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama CIty University Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

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

Yokohama City University IRB

Address

3-9Fukuura,Kanazawa-ku,Yokohama,Kanagawa

Tel

045-787-2800

Email

nextjim1@yokohama-cu.ac.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

横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院(神奈川県)
横浜南共済病院(神奈川県)
済生会横浜市南部病院(神奈川県)
藤沢市民病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 24 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

31

Results

Clinical success rate 87%
Technical success rate 97%

Results date posted

2020 Year 02 Month 24 Day

Results Delayed

Delay expected

Results Delay Reason

Submitting a paper

Date of the first journal publication of results


Baseline Characteristics

Median age:70
Male 19

Participant flow

Duodenl stenting was performed for 31 cases

Adverse events

Stent migration 1
Cholangitis 1
Delayed perforation 1

Outcome measures

Improvement of GOOSS

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2017 Year 07 Month 27 Day

Date of IRB

2017 Year 08 Month 08 Day

Anticipated trial start date

2017 Year 08 Month 24 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2017 Year 08 Month 22 Day

Last modified on

2020 Year 02 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032941


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name