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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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KCT |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
KCT0000391 |
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Date of registration:
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28/03/2012 |
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Primary sponsor: |
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Public title:
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Continuous infusion versus intermittent dosing of pantoprazole for the prevention of bleeding after endoscopic submucosal dissection : A prospective randomized trial
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Scientific title:
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Continuous infusion versus intermittent dosing of pantoprazole for the prevention of bleeding after endoscopic submucosal dissection : A prospective randomized trial |
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Date of first enrolment:
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2012-04-02 |
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Target sample size:
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400 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=1931 |
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Study type:
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Interventional Study |
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Study design:
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Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Open, Allocation : RCT
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Bong Eun
Lee |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pusan National University Hospital |
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Name:
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Geun Am
Song |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pusan National University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: a. gastric adenoma(no limitation in size)
b. early gastric cancer /c no LN involvement and metastasis by abdominal CT (expanded criteria by Gotoda et. al)
? differentiated type
- mucosal cancer without ulcer finding irrespective of tumor size
- mucosal caner with ulcer finding = 3cm
- minute (<500um from muscularis mucosa) submucosal invasive cancer = 3cm
? undifferentiated type
- mucosal cancer without ulcer finding = 2cm
Exclusion criteria: a. previous history of UGI surgery or vagotomy
b. known hypersensitivity on pantoprazole
c. current use of aspirin, antiplatelet, anticoagulant, NSAIDs, steroid
d. current use of PPI
e. abnormal coagulation profile
f. women either pregnant or at risk of pregnancy
g. lactating women
h. ASA III or IV or severe comorbidity
e. reccured lesion
Age minimum:
N/A(No Limit)
Age maximum:
N/A(No Limit)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neoplasms
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Intervention(s)
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Drug : Group 1 . PPI infusion group
1st & 2nd day : Pantoprazole 80mg loading 2hr before ESD and 8mg/hr iv (continuous)
3rd day: pantoprazole 40mg po for 8weeks
Group 2. PPI intermittent injection group
1st 2nd day day : Pantoprazole 40mg bid iv
3rd day: pantoprazole 40mg po for 8weeks
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Primary Outcome(s)
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delayed bleeding after ESD
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early bleeding after ESD
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Secondary Outcome(s)
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immediate bleeding during ESD
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Source(s) of Monetary Support
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