UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006545 |
|---|---|
| Receipt number | R000007734 |
| Scientific Title | A prospective comparative study to determine whether an infrared imaging system can prevent bleeding after endoscopic submucosal dissection. |
| Date of disclosure of the study information | 2011/10/30 |
| Last modified on | 2011/10/30 11:14:55 |
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Basic information
Public title
A prospective comparative study to determine whether an infrared imaging system can prevent bleeding after endoscopic submucosal dissection.
Acronym
A prospective comparative study to determine whether an infrared imaging system can prevent bleeding after endoscopic submucosal dissection.
Scientific Title
A prospective comparative study to determine whether an infrared imaging system can prevent bleeding after endoscopic submucosal dissection.
Scientific Title:Acronym
A prospective comparative study to determine whether an infrared imaging system can prevent bleeding after endoscopic submucosal dissection.
Region
| Japan |
Condition
Condition
gastric tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic submucosal dissection (ESD) for early gastric neoplasms enables to resect in en block. However, major complication about ESD is post bleeding. The aim of this study is to investigate whether an infrared imaging (IRI) system has potential to reduce the post ESD bleeding.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
to determine whether an infrared imaging system can prevent bleeding after endoscopic submucosal dissection.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A total of 24 patients (25 lesions) were consecutively enrolled in this study between March 2010 and December 2010 at our hospital.
Key exclusion criteria
Exclusion criteria were as follows: 1) patients with a bleeding tendency (liver cirrhosis, dialysis); or 2) age >80 years or <20 years.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yukinaga yoshida |
Organization
Jikei University Aoto hospital
Division name
Department of Endoscopy
Zip code
Address
6-41-2,Aoto Katsushika-ku, Tokyo,Japan
TEL
+81-3-3603-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yukinaga yoshida |
Organization
Jikei University Aoto Hospital
Division name
Department of Endoscopy
Zip code
Address
6-41-2,Aoto Katsushika-ku, Tokyo,Japan
TEL
Homepage URL
Sponsor or person
Institute
Jikei University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
東京慈恵会医科大学附属青戸病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 30 | 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
| 2010 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 01 | Month | 01 | Day |
Other
Other related information
Only gray points on IRI corresponded with a risk of bleeding. Thus, limiting coagulation to these points, with special attention to the peripheral area of the ulcer, may reduce unnecessary coagulation and reduce procedural time while still minimizing the risk of delayed bleeding.
Management information
Registered date
| 2011 | Year | 10 | Month | 14 | Day |
Last modified on
| 2011 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007734
