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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00709046
Other study ID # 200710033M
Secondary ID
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. completion date
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


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
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