Rapid Urease Test for Diagnosis of H. Pylori Infection in Patients With Peptic Ulcer Bleeding
Recruitment status was Recruiting
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- the sensitivity of rapid urease test for H. pylori [ Time Frame: within 2 days ] [ Designated as safety issue: No ]the sensitivity of rapid urease test for H. pylori using 13C-UBT as gold standard
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | August 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Tzong-Hsi Lee, MD | 886-2-89667000 ext 1702 | thleekimo@yahoo.com.tw |
| Contact: Cheng-Kuan Lin, MD | 886-2-89667000 ext 4743 | widelin@mail.femh.org.tw |
| Taiwan | |
| Far Eastern Memorial Hospital | Recruiting |
| New Taipei city, Taiwan, 22060 | |
| Contact: Tzong-Hsi Lee, MD 886-2-89667000 ext 1702 thleekimo@yaho.com.tw | |
| Contact: Cheng-Kuan Lin, MD 886-2-89667000 ext 4743 widelin@mail.femh.org.tw | |
| Principal Investigator: Tzong-Hsi Lee, MD | |
| Principal Investigator: | Tzong-Hsi Lee, MD | Far Eastern Memorial Hospital |
More Information
No publications provided
| Responsible Party: | Tzong-Hsi Lee, Division of Gastroenterology and Hepatology, Far Eastern Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01282853 History of Changes |
| Other Study ID Numbers: | FEMH-99-C-029 |
| Study First Received: | January 23, 2011 |
| Last Updated: | January 23, 2011 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Far Eastern Memorial Hospital:
|
peptic ulcer hemorrhage rapid urease test urea breath test |
Additional relevant MeSH terms:
|
Hemorrhage Peptic Ulcer Peptic Ulcer Hemorrhage Ulcer Helicobacter Infections Pathologic Processes Duodenal Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Gastrointestinal Hemorrhage Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 21, 2013