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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Peptic Ulcer
• Intervention / Treatment: Procedure: endoscopic biopsy

Detailed Description

as brief summary

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei city, Taiwan, 22060
    • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: HelicotecUT plus for rapid urease test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Principal Investigator: Tzong-Hsi Lee, MD, Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: January 23, 2011
• First Submitted That Met QC Criteria: January 23, 2011
• First Posted (ESTIMATE): January 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 28, 2015
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: peptic ulcer; hemorrhage; rapid urease test; urea breath test
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Ulcer; Hemorrhage; Peptic Ulcer
• Other Study ID Numbers: FEMH-99-C-029