UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018612 |
|---|---|
| Receipt number | R000021541 |
| Scientific Title | Efficacy of traction assisted endoscopic submucosal dissection using clip and line for colorectal neoplasms: a randomized controlled trial |
| Date of disclosure of the study information | 2015/08/09 |
| Last modified on | 2017/01/10 17:05:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of traction assisted endoscopic submucosal dissection using clip and line for colorectal neoplasms: a randomized controlled trial
Acronym
TAC STUDY
Scientific Title
Efficacy of traction assisted endoscopic submucosal dissection using clip and line for colorectal neoplasms: a randomized controlled trial
Scientific Title:Acronym
TAC STUDY
Region
| Japan |
Condition
Condition
colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of traction assisted endoscopic submucosal dissection using clip and line for colorectal neoplasms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ESD procedure time which is measured from the start of the submucosal injection until removal of the lesion
Key secondary outcomes
Self-completion rate, R0 resection rate, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Conventional ESD group
Interventions/Control_2
Traction assisted ESD group
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
1 Colorectal neoplasms larger than 20 mm that were difficult to remove en bloc with conventional EMR
2 Colorectal neoplasms predicted to be non-invasive tumors and cancers with minute (less than 1000um) submucosal invasion
Key exclusion criteria
1 residual lesions after EMR
2 patients with IBD or FAP
3 patients with hematological abnormality
4 patients with severe organ failure
5 patients who have been judged as in appropriate for this study
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoji Takeuchi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL
+81-6-6972-1181
takeuti-yo@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Yamasaki |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL
+81-6-6972-1181
Homepage URL
yasshifive@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
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
大阪府立成人病センター(大阪府)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2015 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 09 | Day |
Last modified on
| 2017 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021541
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
