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Rapid Urease Test for Diagnosis of H. Pylori Infection in Patients With Peptic Ulcer Bleeding

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01282853
First Posted: January 25, 2011
Last Update Posted: August 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tzong-Hsi Lee, Far Eastern Memorial Hospital
  Purpose

Rapid urease test (RUT) is the most commonly used biopsy-based method to diagnose Helicobacter pylori (Hp) infection because of its simple, rapid and accurate characters. However, its sensitivity was reported to decrease during ulcer bleeding recently. So it is an important issue to avoid a false negative test in these patients. Siddique et al reported that the sensitivity of RUT could be increased when the biopsy number increased from 1 to 4. Other studies demonstrated that additional biopsy from gastric body would increased the sensitivity of RUT in patients with ulcer bleeding. Therefore, we design this study to see if increased number of biopsy or different location of biopsy could increase sensitivity of RUT in patients with gastroduodenal ulcer bleeding.

After receiving explanation and giving consent, these patients with gastric or duodenal ulcer bleeding diagnosed after endoscopic examination will be enrolled. Those who are unstable, have received antibiotic or continuous proton pump inhibitor treatment within 4 weeks, or are contraindicated for endoscopic biopsy will be excluded. We will take 1 piece, 4 pieces of biopsy samples from prepyloric antrum and 1 piece from gastric body with standard biopsy forceps from the patients after they agree for RUT test. Then, we put these samples into 3 separate RUT kits respectively. We use 13C-UBT as gold standard for diagnosis of Hp infection. It is scheduled: (1) if the condition of this patient is not suitable for breath test just after endoscopic examination, 13C-UBT will be performed within 2 days,(2) otherwise, it will be performed 1 hour after examination. We plan to enroll 100 patients for this study. We will apply McNamer's test to examine the difference of RUT sensitivity of different biopsy number. For the RUT sensitivity from different locations, we use kappa statistic method to analyze their consistency.


Condition Intervention
Peptic Ulcer Hemorrhage Procedure: endoscopic biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Influence of Biopsy Number and Site on the Sensitivity of Rapid Urease Test for Diagnosis of H. Pylori Infection in Patients With Bleeding Gastroduodenal Ulcer

Resource links provided by NLM:


Further study details as provided by Tzong-Hsi Lee, Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • the sensitivity of rapid urease test for H. pylori [ Time Frame: within 2 days ]
    the sensitivity of rapid urease test for H. pylori using 13C-UBT as gold standard


Enrollment: 116
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1
one biopsy specimen taken from gastric antrum was put into RUT kit
Procedure: endoscopic biopsy
endoscopic biopsy for rapid urease test
Other Name: HelicotecUT plus for rapid urease test
Experimental: A4
4 biopsy specimens taken from gastric antrum were put into RUT kit
Procedure: endoscopic biopsy
endoscopic biopsy for rapid urease test
Other Name: HelicotecUT plus for rapid urease test
Experimental: B1
one biopsy specimen taken from gastric body was put into RUT kit
Procedure: endoscopic biopsy
endoscopic biopsy for rapid urease test
Other Name: HelicotecUT plus for rapid urease test

Detailed Description:
as brief summary
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gastroduodenal ulcer with bleeding, documented by endoscopic examination

Exclusion Criteria:

  • 1. receiving continuous proton pump inhibitor treatment, antibiotics within 4 weeks 2. not suitable for endoscopic biopsy 3. hemodynamically unstable
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282853


Locations
Taiwan
Far Eastern Memorial Hospital
New Taipei city, Taiwan, 22060
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Tzong-Hsi Lee, MD Far Eastern Memorial Hospital
  More Information

Responsible Party: Tzong-Hsi Lee, M.D., Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01282853     History of Changes
Other Study ID Numbers: FEMH-99-C-029
First Submitted: January 23, 2011
First Posted: January 25, 2011
Last Update Posted: August 31, 2015
Last Verified: January 2011

Keywords provided by Tzong-Hsi Lee, Far Eastern Memorial Hospital:
peptic ulcer
hemorrhage
rapid urease test
urea breath test

Additional relevant MeSH terms:
Ulcer
Hemorrhage
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases