UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020624 |
|---|---|
| Receipt number | R000023803 |
| Scientific Title | Oral prednisolone in the treatment of esophageal stricture after esophageal surgery |
| Date of disclosure of the study information | 2016/01/18 |
| Last modified on | 2018/03/24 23:41:20 |
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Basic information
Public title
Oral prednisolone in the treatment of esophageal stricture after esophageal surgery
Acronym
Oral prednisolone in the treatment of esophageal stricture after esophageal surgery
Scientific Title
Oral prednisolone in the treatment of esophageal stricture after esophageal surgery
Scientific Title:Acronym
Oral prednisolone in the treatment of esophageal stricture after esophageal surgery
Region
| Japan |
Condition
Condition
Esophageal strictures
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and Proof-of-concept
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety and Success rate
Key secondary outcomes
The rate of re-strictures at 85 POD, dysphagia score, the session of the dilatation, body weight, biomarker, and endoscopic findings
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
| Medicine |
Interventions/Control_1
Oral Prednisone for 12 weeks
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
The patients who develop the severe esophageal strictures from 28 days after esophageal surgery
Key exclusion criteria
Pulmonary and cardiac disorders
Liver and renal dysfunctions
Allergic
Pregnancy
infectious disease
Unsuitable condition
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eguchi Susumu |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgery
Zip code
Address
Sakamoto 1-7-1, Nagasaki city
TEL
+81958197316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Kobayashi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgery
Zip code
Address
Sakamoto 1-7-1, Nagasaki city
TEL
+81958197316
Homepage URL
shinichirokobayashi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aids for scientific research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
長崎大学病院、長崎医療センター（長崎県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 10 | 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
| 2016 | Year | 01 | Month | 18 | Day |
Last modified on
| 2018 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023803
