Oral Versus IV Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Endoscopic Hemostasis

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 treatment with proton pump inhibitor (PPI) after initial endoscopic hemostasis reduced recurrent ulcer bleeding. However, the optimal dose and route of adjuvant PPI therapy remains controversial. A recent study demonstrated frequent oral PPI offered similar acid control as currently recommended intravenous infusion PPI did in patients with bleeding ulcers. The investigators hypothesize that an frequent oral PPI treatment has similar benefit as proton pump inhibitor infusion in patient with bleeding ulcers after combined endoscopic hemostasis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Dexlansoprazole; Hemostatics; Lansoprazole; Pantoprazole; Proton Pump Inhibitors

Criteria

Inclusion Criteria:

• Age ≥ 18

• Confirmed ulcer bleeding with Forrest Ia, Ib, IIa

• Endoscopic hemostasis achieved by combined endoscopic hemostasis

• Informed consent obtained

Exclusion Criteria:

• 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