UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031985 |
|---|---|
| Receipt number | R000036449 |
| Scientific Title | Development of predictive and preventive methods for post-esophageal ESD stricture |
| Date of disclosure of the study information | 2018/04/15 |
| Last modified on | 2023/04/03 13:26:38 |
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Basic information
Public title
Development of predictive and preventive methods for post-esophageal ESD stricture
Acronym
Clinical predictor and prevention of esophageal stricture
Scientific Title
Development of predictive and preventive methods for post-esophageal ESD stricture
Scientific Title:Acronym
Clinical predictor and prevention of esophageal stricture
Region
| Japan |
Condition
Condition
superficial esophageal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify risk factors for esophageal stricture after preventive steroid therapy and examine additional preventive therapy before stricture formation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stricture-free survival
Key secondary outcomes
the number of endoscopic balloon dilation for 12 weeks after ESD, adverse events and proportion of patients with dysphagia score=<1 at the time of 12 weeks after ESD
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A: After local steroid (triamcinolone acetonide 100 mg) injection to the ulcer, prednisolone is started on post-operative day 3 at a dose of 30 mg/day. The administration of steroids was discontinued after 12 weeks.
Interventions/Control_2
B: After local steroid (triamcinolone acetonide 100 mg) injection to the ulcer, patients receive no additional treatment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients over 20 years of age
2)Patients who are histologically proven esophageal squamous cell carcinoma or intraepithelial neoplasia
3)Patients with primary tumor located in the epithelium, lamina propria mucosa, muscularis mucosa or submucosa confirmed by endoscopy
4)Patients with dysphagia score of 0
5)Patients who admit to a hospital
6)Patients with written informed consent.
Key exclusion criteria
1)Patients with prior radiotherapy to the neck, chest wall, lung, or mediastinum
2)Patients with primary tumor located within 20mm from prior EMR/ESD treatment site
3)Patients who fail to pass through the prior EMR/ESD treatment site by a standard endoscope (for the upper gastrointestinal tract)
4)Patients with surgery or radiotherapy for esophagus within 3 months after esophageal ESD
5)Patients who judged inappropriate by an attendant physician
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Mikihiro |
| Middle name | |
| Last name | Fujiya |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166-68-2462
fjym@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Takahashi |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166-68-2462
Homepage URL
ktakaha@asahikawa-med.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Asahikawa-Kosei General Hospital
Asahikawa City hospital
Japanese Red Cross Asahikawa Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
Tel
0166-68-2297
rs-kk.g@asahikawa-med.ac.jp
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
| 2018 | Year | 04 | Month | 15 | 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
| 2018 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 28 | 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
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036449
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
