UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007238 |
|---|---|
| Receipt number | R000008352 |
| Scientific Title | Chemically assisted endoscopic submucosal dissection by using mesna for esophageal cancer. |
| Date of disclosure of the study information | 2012/02/07 |
| Last modified on | 2013/05/28 18:31:10 |
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Basic information
Public title
Chemically assisted endoscopic submucosal dissection by using mesna for esophageal cancer.
Acronym
Chemically assisted ESD by using mesna.
Scientific Title
Chemically assisted endoscopic submucosal dissection by using mesna for esophageal cancer.
Scientific Title:Acronym
Chemically assisted ESD by using mesna.
Region
| Japan |
Condition
Condition
Superficial esophageal squamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of mesna as a submucosal injectable solution for the endoscopic submucosal dissection technique.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
En bloc resection rate
Key secondary outcomes
Short and long term complication, duration of procedure, number of coagularion for bleeding
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
ESD after submucosal injection of mesna
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
Superficial esophagial squamous cell carcinoma cases indicated for ESD.
Key exclusion criteria
Patients with allergic history to mesna
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Dobashi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
The Jikei University School of Medicine, Department of Endsocopy
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine, Department of Endsocopy
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
| 2012 | Year | 02 | Month | 07 | 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
An en bloc resection rate was 100%. The mechanical submucosal dissection with mesna for surperficial esophageal neoplasms deem safe and may facilitate procedure of conventional ESD.
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
| 2009 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 28 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 28 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 07 | Day |
Last modified on
| 2013 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008352
| 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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