Ignite Creation Date:
2024-05-05 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00709046
Status:
UNKNOWN
Last Update Posted:
2010-01-12
First Post:
2008-06-30
Brief Title:
High Dose Versus Standard Dose Proton Pump Inhibitor PPI in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Treatment
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2010-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 thermocoagulationhemo-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None