UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029919 |
|---|---|
| Receipt number | R000033909 |
| Scientific Title | Prospective intervention trial to evaluate the effectiveness of PPI for healing of ulcer after ESD |
| Date of disclosure of the study information | 2017/11/10 |
| Last modified on | 2019/05/13 12:32:52 |
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Basic information
Public title
Prospective intervention trial to evaluate the effectiveness of PPI for healing of ulcer after ESD
Acronym
Prospective intervention trial to evaluate the effectiveness of PPI for healing of ulcer after ESD
Scientific Title
Prospective intervention trial to evaluate the effectiveness of PPI for healing of ulcer after ESD
Scientific Title:Acronym
Prospective intervention trial to evaluate the effectiveness of PPI for healing of ulcer after ESD
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In endoscopic ulcers after gastric ESD, the effectiveness of proton pump inhibitor (PPI) on ulcer healing and prevention of postoperative bleeding has been reported, but after esophageal ESD there is no hint of adequate evidence PPI is used in the current situation.
In this study, we will prospectively investigate the effectiveness of PPI for ulcer healing after esophageal cancer ESD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of healing of ulcer 4 weeks after esophagus ESD.
Key secondary outcomes
Presence or absence of healing of ulcer 8 weeks after esophagus ESD.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral PPI for 8 weeks
Interventions/Control_2
Do not take PPI for 8 weeks
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 with lesions whose resected area is expected to be less than three-fourths round
2 With regard to participation in this study, patients who gained document consent by their own voluntary intention
Key exclusion criteria
1 Patients with lesions whose resection range is predicted to be more than three-fourths round
2 Patients who can not receive endoscopic examination for evaluating ulcer healing
3 Patients taking steroids before treatment
4 Patients who have taken PPI from before treatment and can not be discontinued
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinwa Tanaka |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe,650-0017, Japan
TEL
078-382-5774
tanakas@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koki Matsuoka |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Endoscopy
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe,650-0017, Japan
TEL
078-382-5774
Homepage URL
mkouki@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 10 | Day |
Last modified on
| 2019 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033909
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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