UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003894 |
|---|---|
| Receipt number | R000004683 |
| Scientific Title | Intralesional steroid injections for esophageal strictures after endoscopic submucosal dissection for esophageal squamous cell neoplasms: A phaseII trial |
| Date of disclosure of the study information | 2010/07/12 |
| Last modified on | 2011/11/08 14:03:41 |
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Basic information
Public title
Intralesional steroid injections for esophageal strictures after endoscopic submucosal dissection for esophageal squamous cell neoplasms: A phaseII trial
Acronym
A phaseII trial of steroid injection for post ESD esophageal stricture
Scientific Title
Intralesional steroid injections for esophageal strictures after endoscopic submucosal dissection for esophageal squamous cell neoplasms: A phaseII trial
Scientific Title:Acronym
A phaseII trial of steroid injection for post ESD esophageal stricture
Region
| Japan |
Condition
Condition
superficial esophageal squamous cell neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of Intralesional steroid injections for esophageal strictures after endoscopic submucosal dissection for esophageal squamous cell neoplasms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
incidence of esophageal strictures
Key secondary outcomes
frequency of balloon dilations, frequency of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intralesional steroid injections for esophageal strictures after endoscopic submucosal dissection for esophageal squamous cell neoplasms
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
1) histologically confirmed esophageal squamous cell neoplasms
2)invaion depth is estimated within submucosa
3)Circumferece of tumor extension is more than 3/4 of lumen
4)without lymphnode metastasis
5)without organ failure
6)obtained written informed consent
Key exclusion criteria
1)undergoing anticoagulant therapy
2)intraoperative perforation during ESD
3)inappropriate for this trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hanaoka Noboru |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511 Japan.
TEL
06-0972-1181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hanaoka Noboru |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511 Japan.
TEL
Homepage URL
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
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 | 07 | Month | 12 | 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
| 2010 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | 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 | 07 | Month | 08 | Day |
Last modified on
| 2011 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004683
