UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003787 |
|---|---|
| Receipt number | R000004581 |
| Scientific Title | Chemically assisted ESD in the esophagus and the colon |
| Date of disclosure of the study information | 2010/06/21 |
| Last modified on | 2012/11/09 14:53:14 |
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Basic information
Public title
Chemically assisted ESD in the esophagus and the colon
Acronym
CA-ESD in the esophagus and the colon
Scientific Title
Chemically assisted ESD in the esophagus and the colon
Scientific Title:Acronym
CA-ESD in the esophagus and the colon
Region
| Japan |
Condition
Condition
Early stage esophageal cancer, esophageal dysplasia, early stage colonic cancer, and colonic adenoma with an indication of ESD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
ESD has enabled us to radically excise superficial gastrointestinal (GI) tumors at any level of the GI tract regardless of lesion size. However, ESD is technically challenging and may carries a higher risks of complications especially in the esophagus and the colon with thinner mural thickness. Preceding animal and pilot clinical studies demonstrated that the submucosal injection of one of mucolytic agents, so called mesna chemically soften the submucosal tissue plane and facilitate submucosal dissection process in ESD in the stomach. In this study, we will evaluate this chemical effect of mesna for ESD in the esophagus and the colon.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedural success rate
Key secondary outcomes
En bloc resection rate
Complication and side effect rate
The healing process of post-therapeutic ulcerations
Histological analysis of sampled specimens
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
| Maneuver |
Interventions/Control_1
Using mesna as a submucosal injection solution.
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 lesions in the esophagus and the colon with indication of ESD removal.
Key exclusion criteria
History of hypersensitivity to mesna and women who were pregnant, lactating, or hoping to become pregnant during this study period
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuki Sumiyama |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
Address
3-25-8 Nishi Shinbashi, 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 Endoscop
Zip code
Address
TEL
Homepage URL
kaz_sum@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Research fund of The Jikei University School of Medicine, Department of Endoscopy.
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
| 2010 | Year | 06 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
| 2010 | Year | 06 | Month | 19 | Day |
Last modified on
| 2012 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004581
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| Registered date | File name |
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| Registered date | File name |
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