UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016559 |
|---|---|
| Receipt number | R000019214 |
| Scientific Title | Stricture after circumferential and sub-circumferential endoscopic submucosal dissection for large rectal neoplasms |
| Date of disclosure of the study information | 2015/02/20 |
| Last modified on | 2015/02/17 00:42:26 |
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Basic information
Public title
Stricture after circumferential and sub-circumferential endoscopic submucosal dissection for large rectal neoplasms
Acronym
Stricture after circumferential and sub-circumferential endoscopic submucosal dissection for large rectal neoplasms
Scientific Title
Stricture after circumferential and sub-circumferential endoscopic submucosal dissection for large rectal neoplasms
Scientific Title:Acronym
Stricture after circumferential and sub-circumferential endoscopic submucosal dissection for large rectal neoplasms
Region
| Japan |
Condition
Condition
Tumors in rectum
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine strictures of the rectum after ESD
Basic objectives2
Others
Basic objectives -Others
To determine the risk factors for developing strictures of the rectum after ESD and effective therapies for it
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Stricture rate after ESD for large lesions in rectum
Key secondary outcomes
The risk factors for developing strictures of the rectum after ESD and effective therapies for it
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who underwent ESD for the rectal tumors and whose treatments resulted in more than 3/4 circumferential resection at Kobe University Hospital and Kishiwada Tokushukai Hospital between April 2005 and May 2014
Key exclusion criteria
The patients who refused to be involved in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Toyonaga |
Organization
Kobe University Hospital
Division name
Department of Endoscopy
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5774
toyonaga@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Toyonaga |
Organization
Kobe University Hospital
Division name
Department of Endoscopy
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5774
Homepage URL
toyonaga@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University
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
Other administrative information
Date of disclosure of the study information
| 2015 | 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
| 2014 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collected the data about patients who required more than 75% circumferential resection at Kobe University Hospital and Kishiwada Tokushukai Hospital between April 2005 and May 2014, and were evaluated for strictures by follow-up colonoscopy and/or using additional surgical specimens. Then, we investigated the probabilities of post-ESD stricture, risk factors, and the effective stricture treatments.
Management information
Registered date
| 2015 | Year | 02 | Month | 17 | Day |
Last modified on
| 2015 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019214
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
