UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037567 |
|---|---|
| Receipt number | R000042829 |
| Scientific Title | Examination about the usefulness of steroid spraying using a spray tube after esophageal cancer ESD |
| Date of disclosure of the study information | 2019/08/02 |
| Last modified on | 2023/08/05 01:18:50 |
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Basic information
Public title
Examination about the usefulness of steroid spraying using a spray tube after esophageal cancer ESD
Acronym
Steroid spraying using a spray tube after esophageal cancer ESD
Scientific Title
Examination about the usefulness of steroid spraying using a spray tube after esophageal cancer ESD
Scientific Title:Acronym
Steroid spraying using a spray tube after esophageal cancer ESD
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of steroid spraying method using a spray tube for post esophageal ESD ulcer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevention effect of the stenosis by the spraying method using a spraying tube.
Stenosis is assessed by endoscopic findings, dysphagia score, with or without endoscopic balloon dilation.
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Immediately after esophagus ESD, steroids are sprayed using a spray tube (Fine Jet Top). The spray solution is triamcinolone acetonide 40 mg, diluted with saline to a total of 20 ml. Endoscopic follow up after treatment is on the second day, one week, one month, two months after treatment to assess the degree of stenosis, presence or absence of contingencies, and dysphagia score.
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
Patients who undergo ESD for esophageal cancer and are expected to resect 3/4 or more of the lumen.
Key exclusion criteria
Patients judged to be unsuitable for this study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Goto |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
755-8505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi
TEL
0836-22-2243
agoto@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Goto |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
755-8505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi
TEL
0836-22-2243
Homepage URL
agoto@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Yamaguchi University Medical School Hospital
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-u.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
| 2019 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35898149/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35898149/
Number of participants that the trial has enrolled
27
Results
Intralesional steroid infusion using a spray tube is a simple and safe technique that is adequately effective in preventing stenosis.
Results date posted
| 2023 | Year | 08 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study included patients who underwent ESD for superficial esophageal cancer at Yamaguchi University Hospital between November 2018 and May 2021 and had a mucosal defect
involving more than three-quarters of the lumen after resection.
Participant flow
When a lesion with a tumor diameter >5 cm was resected in its entire circumference, a combination of steroid injection and
oral steroids was deemed necessary, and the patient was excluded from the study.
Patients who underwent additional surgical resections after ESD were also excluded because of their need for rapid treatment.
Adverse events
Stenosis was identified in five patients (18.5%), and EBD was performed.
Outcome measures
Endoscopic examination was performed before treatment, and follow-up examinations were performed 1 week, 1 month, and 2 months after treatment to test scope passage.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042829
