NCT00709046

High Dose Versus Standard Dose Proton Pump Inhibitor (PPI) in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Treatment

High Dose Versus Standard Dose Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Hemostasis: A Prospective Randomized Comparative Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The study was designed to evaluate the efficacy an adjuvant use of standard dose or high dose of proton pump inhibitor after combined endoscopic hemostasis therapy.

Detailed description

Acute peptic ulcer bleeding remains the most common cause of acute upper gastrointestinal bleeding. Endoscopy serves as a tool for initial diagnosis and triage and also a tool for immediate hemostasis, especially for high-risk lesions. High-risk lesions include peptic ulcers with active spurting vessel, oozing vessel, or NBVV, nonbleeding visible vessel. Current modalities of endoscopic hemostasis include epinephrine injection, endoscopic coaptive thermocoagulation, hemoclipping. Endoscopic hemostasis has been documented by a number of clinical studies to be effective in decreasing rebleeding, need for emergency surgery, decreasing hospitalization days. Current evidence also shows that combination therapy with epinephrine injection and heater probe thermocoagulation/hemo-clip hemostasis is more effective than epinephrine injection alone or than heater probe thermocoagulation alone, or than hemoclip hemostasis alone. Studies showed a high dose intravenous proton pump inhibitor infusion after initial endoscopic hemostasis reduced recurrent ulcer bleeding. However, it was still controversial whether an adjuvant use of standard-dose proton pump inhibitor therapy to endoscopic therapy had similar benefit. We hypothesized that an adjuvant use of standard dose of proton pump inhibitor after combined endoscopic hemostasis therapy offer similar benefit as high dose proton pump inhibitor did.

Conditions

• Endoscopy
• Peptic Ulcer
• Bleeding
• Proton Pump Inhibitors

Interventions

Type	Name	Description
DRUG	High dose pantoprazole infusion	Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs
DRUG	Standard dose pantoprazole infusion	Pantoprazole 40mg iv bolus qd x 3 days

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-01-01
• First posted: 2008-07-03
• Last updated: 2010-01-12

Locations

1 site across 1 country: Taiwan