UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000688 |
|---|---|
| Receipt number | R000000825 |
| Scientific Title | Efficacy and safety of two weeks rabeprazole treatment for gastric ulcers after endoscopic submucosal dissection (ESD). |
| Date of disclosure of the study information | 2007/04/23 |
| Last modified on | 2010/06/05 08:49:47 |
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Basic information
Public title
Efficacy and safety of two weeks rabeprazole treatment for gastric ulcers after endoscopic submucosal dissection (ESD).
Acronym
Two weeks rabeprazole for ESD ulcers.
Scientific Title
Efficacy and safety of two weeks rabeprazole treatment for gastric ulcers after endoscopic submucosal dissection (ESD).
Scientific Title:Acronym
Two weeks rabeprazole for ESD ulcers.
Region
| Japan |
Condition
Condition
early gastric cancer or gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the healing rate of gastric artificial ulcers after ESD using rabeprazole for 2 weesks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of ulcers in scarring stage at 8 weeks after ESD.
Key secondary outcomes
Incidence of post-operative bleeding and abdominal symptoms.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. gastric adenoma or early gastric carcinoma diagnosed as clinical stage IA.
2. 20 years or older who provided written informed consent.
3. Performance status ECOG 0, 1, 2.
4. Patients who could attend our hospital for 2 months after ESD.
Key exclusion criteria
1. Patients whose lesions were diagnosed as: depth more than sm2, resected margin positive of tumor, lesions with ulcer, tumor with diffuse type cancer.
2. Patients who required surgical intervention after ESD.
3. Patients with 2 or more lesions.
4. Patients who are allergic to PPI.
5. Patients with serious comorbid diseases.
6. Patients taking NSAIDs, steroid, anticoagulants and antiplatelets.
7. Patients who were judged inappropriate by their physicians.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Fujishiro |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyoku, Tokyo, 113-8655
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
The University of Tokyo, Department of Gastroenterology
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
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
| 2007 | Year | 04 | Month | 23 | 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
Completed
Date of protocol fixation
| 2007 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Generally, the lesion should be removed in one piece by ESD. Rabeprazole is administered from the day before ESD. Endoscopy is perfomed 1 and 8 weeks after ESD. The ulcer stage is recorded at each endoscopy. Post-operative bleeding is defined as hematemesis, tarry stool or decrease of hemoglobin level 2mg/dl or more. Symptom assessment is made by questionnare at 1, 4, 8 weeks after ESD.
Management information
Registered date
| 2007 | Year | 04 | Month | 23 | Day |
Last modified on
| 2010 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000825
