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Recruitment status Terminated
Unique ID issued by UMIN UMIN000004249
Receipt No. R000005103
Scientific Title The feasibility of a metalic stent for Esophageal benign stricture after endoscopic submucosal dissection for esophageal squamous cell neoplasms
Date of disclosure of the study information 2010/09/22
Last modified on 2013/03/24

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Basic information
Public title The feasibility of a metalic stent for Esophageal benign stricture after endoscopic submucosal dissection for esophageal squamous cell neoplasms
Acronym Metalic stent for esophageal benign stricture
Scientific Title The feasibility of a metalic stent for Esophageal benign stricture after endoscopic submucosal dissection for esophageal squamous cell neoplasms
Scientific Title:Acronym Metalic stent for esophageal benign 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 evaluate the feasibility of the metalic stent placement, followed by stent removal after a period, for esophageal benign stricture after endoscopic submucosal dissection for superficial esophageal squamous cell neoplasms.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Incidence of the complication related with metalic stent placement.
Key secondary outcomes 1) Incidence of the re-stricture after stent removal
2) Duration of stricture-free or symptom-free period

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
Device,equipment
Interventions/Control_1 Place a metalic stent for esophageal benign stricture.
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. age; 20-80 years-old
2. with esophageal benign stricture after endoscopic submucosal dissection for esophageal squamous cell neoplasms.
3. with re-stricture after endoscopic balloon dilation for esophageal benign stricture.
4. Performance status: 0, 1.
5. with or without multiple stricture.
6. without organ failure.
7. without serious complication.
8. obtained written informed consent.
Key exclusion criteria 1. post operative status of esophagectomy.
2. with overt infection or inflammation of esophagus.
3. inappropriate for this study.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohisa Machida
Organization Osaka City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-4-3, Asahi-machi, Abeno, Osaka, Japan
TEL 06-6645-3811
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirohisa Machida
Organization Osaka City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-4-3, Asahi-machi, Abeno, Osaka, Japan
TEL 06-6645-3811
Homepage URL
Email

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka City University Graduate School of Medicine
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 09 Month 22 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 Terminated
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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 09 Month 22 Day
Last modified on
2013 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005103

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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