High Dose Versus Standard Dose Proton Pump Inhibitor (PPI) in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Treatment
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Endoscopy Peptic Ulcer Bleeding Proton Pump Inhibitors |
Drug: High dose pantoprazole infusion Drug: Standard dose pantoprazole infusion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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 |
- rate of initial hemostasis and the rate of recurrent bleeding [ Time Frame: 72hr ] [ Designated as safety issue: Yes ]
- need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality [ Time Frame: 30day ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
High dose pantoprazole infusion
|
Drug: High dose pantoprazole infusion
Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs
Other Name: Pantoloc
|
|
Active Comparator: 2
standard dose pantoprazole infusion
|
Drug: Standard dose pantoprazole infusion
Pantoprazole 40mg iv bolus qd x 3 days
Other Name: Pantoloc
|
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Chieh-Chang Chen, MD | 886-5-532-3911 ext 2200 | chiehchang.chen@gmail.com |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Chieh-Chang Chen, MD 886-5-532-3911 ext 2200 chiehchang.chen@gmail.com | |
More Information
No publications provided by National Taiwan University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chieh-Chang Chen, National Taiwan Univeritsy Hospital |
| ClinicalTrials.gov Identifier: | NCT00709046 History of Changes |
| Other Study ID Numbers: | 200710033M |
| Study First Received: | June 30, 2008 |
| Last Updated: | January 11, 2010 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Endoscopic treatment Peptic ulcer Bleeding Thermocoagulation Proton pump inhibitors |
Additional relevant MeSH terms:
|
Hemorrhage Peptic Ulcer Peptic Ulcer Hemorrhage Ulcer Pathologic Processes Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases |
Gastrointestinal Hemorrhage Pantoprazole Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013