Clinical trial NCT00709046: High Dose Versus Standard Dose Proton Pump Inhibitor (PPI) in High-risk Bleeding Peptic Ulcers After Combined Endoscopic 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopy
Peptic Ulcer
Bleeding
Proton Pump Inhibitors
Keywords: Endoscopic treatment
Peptic ulcer
Bleeding
Thermocoagulation
Proton pump inhibitors
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-07-03
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of initial hemostasis and the rate of recurrent bleeding
timeFrame: 72hr
Secondary outcomes:
measure: need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality
timeFrame: 30day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
citation: 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.