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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00709046
• Other study ID #: 200710033M
• Status: Recruiting
• Phase: N/A
• First received: June 30, 2008
• Last updated: January 11, 2010
• Start date: January 2008

Study information

• Verified date: January 2010
• Source: National Taiwan University Hospital
• Contact: Chieh-Chang Chen, MD
• Phone: 886-5-532-3911
• Email: chiehchang.chen[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• adults aged above 16 years old with acute nonvariceal upper gastrointestinal bleeding

• read, agree to attend the study, and signed informed consent indicated to receive esophagogastroduodenoscopy(EGD)

• peptic ulcers with high risk lesions (active bleeding: spurting, oozing peptic ulcers. Ulcers with NBVV: nonbleeding visible vessel)

Exclusion Criteria:

• unable to receive EGD (unable to open mouth, upper gastrointestinal obstruction)

• bleeding tendency (platelet < 50x109/L, prothrombin time INR >2, ongoing use of heparin or coumadin)

• gastric malignancy

• myocardial infarction within recent one week

• recent cerebrovascular event within recent one week

• pregnancy

• refuse to attend the study

• known allergy history to epinephrine or pantoprazole

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding
• Endoscopy
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Proton Pump Inhibitors
• Ulcer

Intervention

Drug:
• High dose pantoprazole infusion
Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs
• Standard dose pantoprazole infusion
Pantoprazole 40mg iv bolus qd x 3 days

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of initial hemostasis and the rate of recurrent bleeding		72hr	Yes
Secondary	need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality		30day	Yes