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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023306
Receipt No. R000026833
Scientific Title Risk factors for bleeding after endoscopic submucosal dissection for gastric lesions
Date of disclosure of the study information 2016/07/23
Last modified on 2016/07/30

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Basic information
Public title Risk factors for bleeding after endoscopic submucosal dissection for gastric lesions
Acronym Risk factors of post ESD bleeding for gastric lesions
Scientific Title Risk factors for bleeding after endoscopic submucosal dissection for gastric lesions
Scientific Title:Acronym Risk factors of post ESD bleeding for gastric lesions
Region
Japan

Condition
Condition gastric neplasma(cancer or adenoma)
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine risk factors for post-endoscopic submucosal dissection (ESD) bleeding.
Basic objectives2 Others
Basic objectives -Others Assessment and evaluation for antithromobotic user
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We analyzed patients who underwent ESD for gastric neoplasms between January 1, 2011 and December 31, 2014 in Kagawa Prefectural Central Hospital. Second-look endoscopy was performed five days after ESD, and post-ESD bleeding before and after the second-look was defined as early and delayed post-ESD bleeding, respectively. We identified risk factors for post-ESD bleeding by using logistic regression analysis.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients underwent endoscopic submucosal dissection(ESD) for gastric neoplasma
Key exclusion criteria Lost to follow up and death case
Target sample size 330

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Izumikawa
Organization Kagawa Prefectural Central Hospital
Division name Department of Gastroenterology
Zip code
Address 1-2-1 Asahi-machi,Takamatsu,Kagawa, Japan 760-8557
TEL 087-811-3333
Email ishikawa5308@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Izumikawa
Organization Kagawa Prefectural Central Hospital
Division name Department of Gastroenterology
Zip code
Address -2-1 Asahi-machi,Takamatsu,Kagawa, Japan 760-8557
TEL 087-811-3333
Homepage URL
Email ishikawa5308@yahoo.co.jp

Sponsor
Institute Kagawa Prefectural Central Hospital
Institute
Department

Funding Source
Organization Kagawa Prefectural Central Hospital
Organization
Division
Category of Funding Organization Local Government
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 07 Month 23 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 Completed
Date of protocol fixation
2011 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This retrospective study was performed in Kgawa Prfectural Central Hosp.
A total of 330 patients underwent ESD for 369 gastric neoplasms between January 2011 and December 2014. The main outcome was association between post-ESD bleeding and the following: age; sex; comorbidities; location, size, and ulceration; experience of operator coagulating the ulcer floor, and use of antithrombotic agents.
Risk factors for postoperative bleeding after ESD (early, delayed, and overall [combined] occurrence of bleeding during the first 5 postoperative days or thereafter) were analyzed by using logistic regression analysis.

Management information
Registered date
2016 Year 07 Month 23 Day
Last modified on
2016 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026833

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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