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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.
as brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator | one biopsy specimen taken from gastric antrum was put into RUT kit |
|
| A4 | Experimental | 4 biopsy specimens taken from gastric antrum were put into RUT kit |
|
| B1 | Experimental | one biopsy specimen taken from gastric body was put into RUT kit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic biopsy | Procedure | endoscopic biopsy for rapid urease test |
|
| Measure | Description | Time Frame |
|---|---|---|
| the sensitivity of rapid urease test for H. pylori | the sensitivity of rapid urease test for H. pylori using 13C-UBT as gold standard | within 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tzong-Hsi Lee, MD | Far Eastern Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Memorial Hospital | New Taipei City | Taiwan | 22060 | Taiwan |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| endoscopic biopsy | Procedure | endoscopic biopsy for rapid urease test |
|
|
| endoscopic biopsy | Procedure | endoscopic biopsy for rapid urease test |
|
|
| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |