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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031985
Receipt No. 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 2018/03/29

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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
Middle name
Last name Mikihiro Fujiya
Organization Asahikawa Medical University
Division name Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Zip code
Address 2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
TEL 0166-68-2462
Email fjym@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keitaro Takahashi
Organization Asahikawa Medical University
Division name Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Zip code
Address 2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
TEL 0166-68-2462
Homepage URL
Email ktakaha@asahikawa-med.ac.jp

Sponsor
Institute Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University
Institute
Department

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
Address
Tel
Email

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
2018 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036449

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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