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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000688
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute The University of Tokyo, Department of Gastroenterology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000825

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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