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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00709046
Enrollment
150
Registered
2008-07-03
Start date
2008-01-31
Completion date
Unknown
Last updated
2010-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Endoscopy, Peptic Ulcer, Proton Pump Inhibitors

Keywords

Endoscopic treatment, Peptic ulcer, Bleeding, Thermocoagulation, Proton pump inhibitors

Brief 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.

Interventions

DRUGHigh dose pantoprazole infusion

Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs

DRUGStandard dose pantoprazole infusion

Pantoprazole 40mg iv bolus qd x 3 days

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
rate of initial hemostasis and the rate of recurrent bleeding72hr

Secondary

MeasureTime frame
need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality30day

Countries

Taiwan

Contacts

Primary ContactChieh-Chang Chen, MD
chiehchang.chen@gmail.com886-5-532-3911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026