UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023306
Receipt number 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 11:53:08

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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 or person

Institute

Kagawa Prefectural Central Hospital

Institute

Department

Personal name



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

Value
https://center6.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