High Dose Versus Standard Dose Proton Pump Inhibitor (PPI) in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Treatment
Primary Purpose
Endoscopy, Peptic Ulcer, Bleeding
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
High dose pantoprazole infusion
Standard dose pantoprazole infusion
Sponsored by
About this trial
This is an interventional treatment trial for Endoscopy focused on measuring Endoscopic treatment, Peptic ulcer, Bleeding, Thermocoagulation, Proton pump inhibitors
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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
High dose pantoprazole infusion
standard dose pantoprazole infusion
Outcomes
Primary Outcome Measures
rate of initial hemostasis and the rate of recurrent bleeding
Secondary Outcome Measures
need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality
Full Information
NCT ID
NCT00709046
First Posted
June 30, 2008
Last Updated
January 11, 2010
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00709046
Brief Title
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
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopy, Peptic Ulcer, Bleeding, Proton Pump Inhibitors
Keywords
Endoscopic treatment, Peptic ulcer, Bleeding, Thermocoagulation, Proton pump inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
High dose pantoprazole infusion
Arm Title
2
Arm Type
Active Comparator
Arm Description
standard dose pantoprazole infusion
Intervention Type
Drug
Intervention Name(s)
High dose pantoprazole infusion
Other Intervention Name(s)
Pantoloc
Intervention Description
Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs
Intervention Type
Drug
Intervention Name(s)
Standard dose pantoprazole infusion
Other Intervention Name(s)
Pantoloc
Intervention Description
Pantoprazole 40mg iv bolus qd x 3 days
Primary Outcome Measure Information:
Title
rate of initial hemostasis and the rate of recurrent bleeding
Time Frame
72hr
Secondary Outcome Measure Information:
Title
need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality
Time Frame
30day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chieh-Chang Chen, MD
Phone
886-5-532-3911
Ext
2200
Email
chiehchang.chen@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chieh-Chang Chen, MD
Phone
886-5-532-3911
Ext
2200
Email
chiehchang.chen@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
22369682
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.
Results Reference
derived
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High Dose Versus Standard Dose Proton Pump Inhibitor (PPI) in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Treatment
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