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
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
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
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
