High Dose Versus Standard Dose Proton Pump Inhibitor (PPI) in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00709046
First received: June 30, 2008
Last updated: January 11, 2010
Last verified: January 2010

June 30, 2008
January 11, 2010
January 2008
January 2010   (final data collection date for primary outcome measure)
rate of initial hemostasis and the rate of recurrent bleeding [ Time Frame: 72hr ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00709046 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Endoscopy
  • Peptic Ulcer
  • Bleeding
  • Proton Pump Inhibitors
  • Drug: High dose pantoprazole infusion
    Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs
    Other Name: Pantoloc
  • Drug: Standard dose pantoprazole infusion
    Pantoprazole 40mg iv bolus qd x 3 days
    Other Name: Pantoloc
  • Experimental: 1
    High dose pantoprazole infusion
    Intervention: Drug: High dose pantoprazole infusion
  • Active Comparator: 2
    standard dose pantoprazole infusion
    Intervention: Drug: Standard dose pantoprazole infusion
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
January 2010   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact: Chieh-Chang Chen, MD 886-5-532-3911 ext 2200 chiehchang.chen@gmail.com
Taiwan
 
NCT00709046
200710033M
Yes
Chieh-Chang Chen, National Taiwan Univeritsy Hospital
National Taiwan University Hospital
Not Provided
Not Provided
National Taiwan University Hospital
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP