Continuous infusion versus intermittent dosing of pantoprazole for the prevention of bleeding after endoscopic submucosal dissection : A prospective randomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000391

Enrollment

400

Registered

2012-03-28

Start date

2012-04-16

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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 gr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
early bleeding after ESD;delayed bleeding after ESD	—

Secondary

Measure	Time frame
immediate bleeding during ESD	—

Countries

Korea, Republic of

Contacts

Public ContactBong Eun Lee

Pusan National University Hospital

Outcome results