Oral Versus IV Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Endoscopic Hemostasis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01182597
First received: August 12, 2010
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

Endoscopic hemostasis has been documented by a number of clinical studies to be effective in decreasing rebleeding, need for emergency surgery, and hospitalization days. Studies showed adjuvant treatment with proton pump inhibitor (PPI) after initial endoscopic hemostasis reduced recurrent ulcer bleeding. However, the optimal dose and route of adjuvant PPI therapy remains controversial. A recent study demonstrated frequent oral PPI offered similar acid control as currently recommended intravenous infusion PPI did in patients with bleeding ulcers. The investigators hypothesize that an frequent oral PPI treatment has similar benefit as proton pump inhibitor infusion in patient with bleeding ulcers after combined endoscopic hemostasis.


Condition Intervention Phase
Peptic Ulcers
Drug: Pantoprazole (Pantoloc)
Drug: Lansoprazole (Takepron OD)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Versus Intravenous Proton Pump Inhibitor Treatment in High-risk Bleeding Peptic Ulcers After Endoscopic Hemostasis: a Prospective Randomized Comparative Study

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Clinical rebleeding [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    Clinical rebleeding defines:

    1. Hematemesis, fresh blood in the NG tube aspirate
    2. Hematochezia/melena after a normal stool
    3. Decrease in Hb >= 2 g/dL or an increase in Hb < 1 g/dL during 24 hrs, despite >=2 units of blood transfused during 24 hours
    4. SBP <= 90 mm Hg or HR >= 110 beats/min AND melena/hematemesis


Secondary Outcome Measures:
  • Blood transfusion [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Need of surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Lengths of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Mortality rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: August 2010
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IV PPI
Pantoprazole 3.3mg/hr for 72hrs
Drug: Pantoprazole (Pantoloc)
Pantoprazole (Pantoloc) 3.3mg/hr for 72hrs
Experimental: Oral PPI
Lansoprazole (Takepron OD) 30mg PO q12h
Drug: Lansoprazole (Takepron OD)
Lansoprazole (Takepron OD) 30mg q12h PO

Detailed Description:

Acute peptic ulcer bleeding remains a therapeutic challenge with significant morbidity and mortality. Endoscopic therapy using various modalities significantly reduces re-bleeding, need for surgery and mortality in patients with peptic ulcer bleeding. Endoscopic therapy achieves successful hemostasis in more than 90% of patients, and re-bleeding occurs in 10-30% of patients. Re-bleeding has an important impact on prognosis. Studies showed adjuvant treatment with proton pump inhibitor (PPI) after initial endoscopic hemostasis reduced recurrent ulcer bleeding. Two consensus documents have endorsed a high-dose PPI regimen (80 mg stat followed by an infusion of 8 mg/h for 72 h). The biologically plausible mechanism of benefit of such a high-dose regimen is to promote clot stability by sustaining the intragastric pH above 6. However, the optimal dose and administration route of proton pump inhibitors (PPI) for the prevention of peptic ulcer rebleeding remains unclear.

The use of IV PPIs adds significantly to the cost of patient care in hospital. Recent studies reported oral PPI may have similar acid suppressive effect as high dose PPI infusion. A prospective trial and a retrospective analysis have shown that oral PPI therapy may also be effective in decreasing rebleeding rates in patients with acute gastrointestinal bleeding due to high-risk peptic ulcer disease, and the magnitude of benefit appears similar to what has been demonstrated with IV PPIs. A meta-analysis reported no difference in the magnitude of risk reduction between the oral- and the intravenous-route. Given the significant cost savings over their IV counterparts, oral PPIs would be an attractive choice of therapy in this situation provided that they have a similar efficacy to IV PPIs. However, no studies have directly compared oral and IV PPI therapy in this setting.

We conducted a head-to-head study, comparing two strategies for PPI administration in the prevention of rebleeding, surgery, and death in patients with high-risk bleeding peptic ulcers in whom successful endoscopic hemostasis was achieved.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Confirmed ulcer bleeding with Forrest Ia, Ib, IIa
  • Endoscopic hemostasis achieved by combined endoscopic hemostasis
  • Informed consent obtained

Exclusion Criteria:

  • No consent
  • Unsuccessful endoscopic treatment
  • Upper GI malignancy
  • History of subtotal gastrectomy
  • Bleeding tendency, platelet count < 80x109/L, prothrombin time INR >1.5
  • Myocardial infarction or cerebrovascular accident within one week
  • Ulcer bleeding because of mechanical factors (such as, induction of NG tube)
  • Malignancy or other advanced disease with a life expectancy of < 6 months
  • IV PPI > 40mg within 24hrs before enrollment
  • Decompensated liver cirrhosis
  • Requiring dialysis
  • Pregnant or lactating women
  • History of allergy or severe side effects to lansoparzole or pantoprazole
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182597

Contacts
Contact: Chieh-Chang Chen, MD 88655323911 ext 2200 chiehchang.chen@gmail.com

Locations
Taiwan
National Taiwan Univeristy Hospital Yunlin Branch Recruiting
Dou-liou, Taiwan
Contact: Chieh-Chang Chen, MD    88655323911    chiehchang.chen@gmail.com   
Principal Investigator: Chieh-Chang Chen, MD         
National Taiwan Univeristy Hospital Not yet recruiting
Taipei, Taiwan
Contact: Jyh-Ming Liou, MD         
Principal Investigator: Jyh-Ming Liou, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chieh-Chang Chen, MD National Taiwan University Hospital Yunlin Branch
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital, Attending physician
ClinicalTrials.gov Identifier: NCT01182597     History of Changes
Other Study ID Numbers: 201003039M
Study First Received: August 12, 2010
Last Updated: June 20, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Oral PPI treatment has similar benefit as proton pump inhibitor infusion in patient with bleeding ulcers after combined endoscopic hemostasis

Additional relevant MeSH terms:
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Hemorrhage
Lansoprazole
Dexlansoprazole
Pantoprazole
Proton Pump Inhibitors
Hemostatics
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on October 02, 2014