UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007315 |
|---|---|
| Receipt number | R000008626 |
| Scientific Title | The effectiveness of endoscopic closure for artificial ulcers after colorectal endoscopic submucosal dissection. |
| Date of disclosure of the study information | 2012/02/20 |
| Last modified on | 2013/05/13 21:28:50 |
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Basic information
Public title
The effectiveness of endoscopic closure for artificial ulcers after colorectal endoscopic submucosal dissection.
Acronym
Endoscopic closure for artificial ulcers after colorectal endoscopic submucosal dissection.
Scientific Title
The effectiveness of endoscopic closure for artificial ulcers after colorectal endoscopic submucosal dissection.
Scientific Title:Acronym
Endoscopic closure for artificial ulcers after colorectal endoscopic submucosal dissection.
Region
| Japan |
Condition
Condition
Colorectal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of study was to investigate the efficacy of endoscopic closure for artificial ulcer after colorectal ESD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient characteristics and tumor clinicopathologic features , closure completion rate, closure procedure time, and complications et al.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Endoscopic closure for artificial ulcers after colorectal endoscopic submucosal dissection.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with colorectal tumors after ESD were selected and treated in Kagawa university hospital.
Key exclusion criteria
1.The case of incomplete resection 2.The case which occurs a severe complication during operation,3.Difficulties of endoscopic closure,4 The tumor is located at appendix. 5.The patient has sever cardiopulmonary and cerebral diseases. 6.The case which we do not get the informed consent.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shintaro Fujihara |
Organization
Kagawa University, Faculty of Medicine
Division name
Department of Gastroenterology and Neurology
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kagawa University, Faculty of Medicine
Division name
Department of Gastroenterology and Neurology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kagawa University, Faculty of Medicine
Department of Gastroenterology and Neurology
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 02 | Month | 20 | 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 | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 16 | Day |
Last modified on
| 2013 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008626
