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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003894
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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