Status:
UNKNOWN
Oral Versus IV Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Endoscopic Hemostasis
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Peptic Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Endoscopic hemostasis has been documented by a number of clinical studies to be effective in decreasing rebleeding, need for emergency surgery, and hospitalization days. Studies showed adjuvant treatm...
Detailed Description
Acute peptic ulcer bleeding remains a therapeutic challenge with significant morbidity and mortality. Endoscopic therapy using various modalities significantly reduces re-bleeding, need for surgery an...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Confirmed ulcer bleeding with Forrest Ia, Ib, IIa
- Endoscopic hemostasis achieved by combined endoscopic hemostasis
- Informed consent obtained
Exclusion
- No consent
- Unsuccessful endoscopic treatment
- Upper GI malignancy
- History of subtotal gastrectomy
- Bleeding tendency, platelet count \< 80x109/L, prothrombin time INR \>1.5
- Myocardial infarction or cerebrovascular accident within one week
- Ulcer bleeding because of mechanical factors (such as, induction of NG tube)
- Malignancy or other advanced disease with a life expectancy of \< 6 months
- IV PPI \> 40mg within 24hrs before enrollment
- Decompensated liver cirrhosis
- Requiring dialysis
- Pregnant or lactating women
- History of allergy or severe side effects to lansoparzole or pantoprazole
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT01182597
Start Date
August 1 2010
Last Update
June 21 2012
Active Locations (2)
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1
National Taiwan Univeristy Hospital Yunlin Branch
Douliu, Taiwan, Taiwan
2
National Taiwan Univeristy Hospital
Taipei, Taiwan, Taiwan