UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021023 |
|---|---|
| Receipt number | R000024260 |
| Scientific Title | Short and long term outcomes of the endoscopic submucosal dissection for the colorectal tumors: single center, large, cohort study |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2017/08/17 12:34:30 |
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Basic information
Public title
Short and long term outcomes of the endoscopic submucosal dissection for the colorectal tumors: single center, large, cohort study
Acronym
Outcomes of colorectal ESDs.
Scientific Title
Short and long term outcomes of the endoscopic submucosal dissection for the colorectal tumors: single center, large, cohort study
Scientific Title:Acronym
Outcomes of colorectal ESDs.
Region
| Japan |
Condition
Condition
Colorectal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the short and long term outcomes and risk factors for the complications and difficulty of ESD completion among patients received ESD for the colorectal neoplasms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
En-block R0 resection rate, curative resection rate, complication rate(perforation, postoperative bleeding)
Key secondary outcomes
tumor diameter, resected specimen diameter, macroscopic type, location, pathological characteristics, procedure time, dissection speed
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
20mm or more colorectal adenoma, intramucosal or slightly-invaded submucosal colorectal neoplasms were considered eligible.
Key exclusion criteria
1.Patients whose lesions were found to be outside the guideline or expanded criteria for ESD by the endoscopic characteristics and histological findings of biopsy specimens.
2.Patients in disagreement with informed consent.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Tashima |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
Address
5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL
+81-3-3448-6547
t.tashima1981@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Tashima |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
Address
5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL
+81-3-3448-6547
Homepage URL
t.tashima1981@gmail.com
Sponsor or person
Institute
Tomoaki Tashima
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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 | 02 | Month | 15 | 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
| 2016 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
From April 2007,patients were treated by endoscopic submucosal dissection at NTT Medical Center Tokyo.
Management information
Registered date
| 2016 | Year | 02 | Month | 14 | Day |
Last modified on
| 2017 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024260
