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

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 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


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

Value
https://center6.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