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

Far Eastern Memorial Hospital

Status: Completed

Conditions: Peptic Ulcer; Hemorrhage

Treatments: Procedure: endoscopic biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01282853

FEMH-99-C-029

Details and patient eligibility

About

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.

Full description

as brief summary

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 3 patient groups

A1

Active Comparator group

Description:

one biopsy specimen taken from gastric antrum was put into RUT kit

Treatment:

Procedure: endoscopic biopsy

Procedure: endoscopic biopsy

Procedure: endoscopic biopsy

A4

Experimental group

Description:

4 biopsy specimens taken from gastric antrum were put into RUT kit

Treatment:

Procedure: endoscopic biopsy

Procedure: endoscopic biopsy

Procedure: endoscopic biopsy

B1

Experimental group

Description:

one biopsy specimen taken from gastric body was put into RUT kit

Treatment:

Procedure: endoscopic biopsy

Procedure: endoscopic biopsy

Procedure: endoscopic biopsy