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

NCT01282853 | Completed

• 1 other identifier: FEMH-99-C-029
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peptic Ulcer; Hemorrhage

Keywords

peptic ulcer; hemorrhage; rapid urease test; urea breath test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

A1

ACTIVE COMPARATOR

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

Procedure: endoscopic biopsy

A4

EXPERIMENTAL

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

Procedure: endoscopic biopsy

B1

EXPERIMENTAL

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

Procedure: endoscopic biopsy

Interventions

endoscopic biopsy PROCEDURE

endoscopic biopsy for rapid urease test

Also known as: HelicotecUT plus for rapid urease test

A1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• gastroduodenal ulcer with bleeding, documented by endoscopic examination

You may not qualify if:

• \. receiving continuous proton pump inhibitor treatment, antibiotics within 4 weeks 2. not suitable for endoscopic biopsy 3. hemodynamically unstable

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan, 22060, Taiwan

Location

MeSH Terms

Conditions

Peptic Ulcer; Hemorrhage

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Tzong-Hsi Lee, MD

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 23, 2011
• First Posted: January 25, 2011
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 31, 2015

Record last verified: 2011-01

Locations

TW (1)