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

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EstadoTerminado
Patrocinadores
Far Eastern Memorial Hospital

Palabras clave

Abstracto

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.

Descripción

as brief summary

fechas

Verificado por última vez: 12/31/2010
Primero enviado: 01/22/2011
Inscripción estimada enviada: 01/22/2011
Publicado por primera vez: 01/24/2011
Última actualización enviada: 08/27/2015
Última actualización publicada: 08/30/2015
Fecha de inicio real del estudio: 07/31/2010
Fecha estimada de finalización primaria: 05/31/2011
Fecha estimada de finalización del estudio: 05/31/2011

Condición o enfermedad

Peptic Ulcer
Hemorrhage

Intervención / tratamiento

Procedure: A1

Procedure: A4

Procedure: B1

Fase

-

Grupos de brazos

BrazoIntervención / tratamiento
Active Comparator: A1
one biopsy specimen taken from gastric antrum was put into RUT kit
Procedure: A1
endoscopic biopsy for rapid urease test
Experimental: A4
4 biopsy specimens taken from gastric antrum were put into RUT kit
Procedure: A4
endoscopic biopsy for rapid urease test
Experimental: B1
one biopsy specimen taken from gastric body was put into RUT kit
Procedure: B1
endoscopic biopsy for rapid urease test

Criterio de elegibilidad

Edades elegibles para estudiar 18 Years A 18 Years
Sexos elegibles para estudiarAll
Acepta voluntarios saludablessi
Criterios

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

Salir

Medidas de resultado primarias

1. the sensitivity of rapid urease test for H. pylori [within 2 days]

the sensitivity of rapid urease test for H. pylori using 13C-UBT as gold standard

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