UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010878 |
|---|---|
| Receipt number | R000012728 |
| Scientific Title | Safety and efficacy of steroid pulse therapy to prevent stricture after endoscopic submucosal dissection (ESD) for esophageal cancer |
| Date of disclosure of the study information | 2013/06/05 |
| Last modified on | 2019/12/10 17:12:25 |
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Basic information
Public title
Safety and efficacy of steroid pulse therapy to prevent stricture after endoscopic submucosal dissection (ESD) for esophageal cancer
Acronym
Steroid pulse therapy after ESD for esophageal cancer
Scientific Title
Safety and efficacy of steroid pulse therapy to prevent stricture after endoscopic submucosal dissection (ESD) for esophageal cancer
Scientific Title:Acronym
Steroid pulse therapy after ESD for esophageal cancer
Region
| Japan |
Condition
Condition
early esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examin safety and efficacy about steroid pulse therapy to prevent strictures after ESD of esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Strictures after ESD
Key secondary outcomes
Safety of steroid pulse therapy
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
We do the steroid pulse therapy to prevent strictures after endoscopic submucosal dissection (ESD) for esophageal cancer
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient who will be performed endoscopic treatment for esophageal cancer.
2. Absolute or relative indication of endoscopic treatment within the therapy guidelines for esophageal cancer.
3. ESD is planned for esophageal cancer, and expected to result of a size of not less than three quarters of the circumference.
4. Patient with no prior chemotherapy, radiotherapy, and surgical treatment.
5. ECOG-Perfomance Status is 0 or 1.
6. Adult Patients aged upper 20 years old.
7. Patient with adequate liver and renal function.
8. Patient must sign an informed consent.
Key exclusion criteria
1. Patient with active peptic ulcer in stomach and duodenum.
2. Patient has a history of tuberculosis.
3. Patients who had an acute myocardial infarction.
4. Patients with uncontrolled diabetes mellitus.
5. Patients with continuous systemic steroids medication.
6. Patients with continuous systemic NSAIDs.
7. Patients temporary interruption of antiplatelet agents and anticoagulants is not possible.
8. Patients with severe mental disease or psychotic manifestation.
9. Patients who have been judged as inappropriate for this study for any reasons by the concerning investigation.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ohira |
| Middle name | |
| Last name | Hiromasa |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1202
h-ohira@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Hikichi |
| Middle name | |
| Last name | Takuto |
Organization
Fukushima Medical University Hospital
Division name
Department of Endoscopy
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1583
Homepage URL
takuto@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University School of Medicine, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University School of Medicine, Department of Gastroenterology.
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
IRB
Address
1 Hikarigaoka, Fukushima, Japan
Tel
024-547-1620
rs@fmu.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
福島県立医科大学
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5554574/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5554574/
Number of participants that the trial has enrolled
11
Results
The stricture rate was 54.5% (6/11). The median time until stricture development was 15 days. The median number of EBD sessions required was 2.5. The median duration of EBD was 14.5 days. AEs related to steroid pulse therapy and postprocedure complications were not observed.
Results date posted
| 2019 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 68 patients who underwent ESD for esophageal cancer during the period defined
above, 11 patients with 13 lesions who met the eligibility criteria and did not meet any of the exclusion criteria were
included in this study.
Participant flow
Of the 68 patients who underwent ESD for esophageal cancer during the period defined
above, 11 patients with 13 lesions who met the eligibility criteria and did not meet any of the exclusion criteria were
included in this study.
Adverse events
No AE.
Outcome measures
The primary endpoint was the rate of stricture after esophageal ESD.
Secondary endpoints were the rate of adverse events (AEs) associated with steroid pulse therapy, the time until stricture development in the stricture cases, the frequency and duration of EBD, and the complications of EBD.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 05 | Day |
Last modified on
| 2019 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012728
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