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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | High dose pantoprazole infusion |
|
| 2 | Active Comparator | standard dose pantoprazole infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose pantoprazole infusion | Drug | Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs |
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of initial hemostasis and the rate of recurrent bleeding | 72hr |
| Measure | Description | Time Frame |
|---|---|---|
| need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality | 30day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chieh-Chang Chen, MD | Contact | 886-5-532-3911 | 2200 | chiehchang.chen@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22369682 | Derived | Chen CC, Lee JY, Fang YJ, Hsu SJ, Han ML, Tseng PH, Liou JM, Hu FC, Lin TL, Wu MS, Wang HP, Lin JT. Randomised clinical trial: high-dose vs. standard-dose proton pump inhibitors for the prevention of recurrent haemorrhage after combined endoscopic haemostasis of bleeding peptic ulcers. Aliment Pharmacol Ther. 2012 Apr;35(8):894-903. doi: 10.1111/j.1365-2036.2012.05047.x. Epub 2012 Feb 28. |
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| Standard dose pantoprazole infusion | Drug | Pantoprazole 40mg iv bolus qd x 3 days |
|
|
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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