High Dose Oral Omeprazole in High Risk UGIB
High Dose Oral Omeprazole Versus Standard Continuous Intravenous Pantoprazole in Patient With Peptic Ulcer Bleeding and Undergo Successful Therapeutic Endoscopy; Non-inferiority Randomized Controlled Trial
King Chulalongkorn Memorial Hospital
128 participants
Oct 1, 2020
INTERVENTIONAL
Conditions
Summary
Peptic ulcer bleeding is the most common etiology in upper gastrointestinal bleeding all over the world. After endoscopic treatment, proton pump inhibitor (PPI) is recommended to prevent re-bleeding. Intravenous PPI is recommended as a standard treatment. In the past, there were many trials showing the efficacy of high-dose oral PPI after endoscopic hemostasis but most were industrial sponsor which assessing an expensive PPI. Moreover, the number of patients in those studies were insufficient to confirm a non-inferiority outcome in term of rebleeding by using oral PPI. This study will evaluate a high-dose, local-made PPI (omeprazole) in peptic ulcer treatment after successful endoscopic hemostasis compared to standard IV PPI continuous drip in term of rebleeding, as well as 24-hour gastric pH monitoring.
Eligibility
Inclusion Criteria2
- Patients with peptic ulcer bleeding and endoscopic finding show ulcer with Forrest classification Ia (spurting haemorrhage), IIa (oozing haemorrhage), Ib (non-bleeding visible vessel)
- Age \> 18 years old
Exclusion Criteria8
- Deny to participate
- Pregnancy or lactation
- Low risk peptic ulcer bleeding including clean base ulcer, flat pigmented spot
- Non-peptic ulcer bleeding eg. erosive gastritis/duodenitis, Mallory Weiss tear, esophageal/gastric/duodenal varices, vascular lesions (eg. Dieulafoy) , malignant ulcer
- Bleeding tendency
- Terminal stage of cancer
- ESRD on hemodialysis
- Decompensated liver cirrhosis
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Interventions
Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.
Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT04394663