UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005411 |
|---|---|
| Receipt number | R000006420 |
| Scientific Title | Balloon dilatation followed by steroid injection for anastomotic strictures after esophagectomy |
| Date of disclosure of the study information | 2011/04/08 |
| Last modified on | 2016/04/08 10:15:52 |
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Basic information
Public title
Balloon dilatation followed by steroid injection for anastomotic strictures after esophagectomy
Acronym
BD followed by steroid
Scientific Title
Balloon dilatation followed by steroid injection for anastomotic strictures after esophagectomy
Scientific Title:Acronym
BD followed by steroid
Region
| Japan |
Condition
Condition
patients with anastomotic strictures after esophagectomy
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determin whether balloon dilatation followed by steroid injection for anastomotic strictures is effective or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A frequency of balloon dilatation for anastomotic strictures
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
steroid injection
Interventions/Control_2
physiologic saline injection
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. Patients without a history of balloon dilatation for anastomotic stricture.
2. Patients underwent gastric tube reconstruction.
3. Patients underwent retrosternal or posterior mediastinum reconstruction.
4. Patients without multiple organ failure.
5. Patients with informed concent.
Key exclusion criteria
1. Patients undergoing anticoagulant therapy
2. Patients with agressive tumor
3. Patients with severe diabetes.
4. Inappropriate for this trial.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | noboru hanaoka |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Nakamichi Higashinariku, Osaka, Japan
TEL
06-6972-1181
hanaoka-no@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | noboru hanaoka |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Nakamichi Higashinariku, Osaka, Japan
TEL
06-6972-1181
Homepage URL
hanaoka-no@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Non
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
| 2011 | Year | 04 | Month | 08 | 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
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2011 | Year | 04 | Month | 08 | Day |
Last modified on
| 2016 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006420
