Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01282853
Status:
COMPLETED
Last Update Posted:
2015-08-31
First Post:
2011-01-23
Brief Title:
Rapid Urease Test for Diagnosis of H Pylori Infection in Patients With Peptic Ulcer Bleeding
Sponsor:
Far Eastern Memorial Hospital
Organization:
Far Eastern Memorial Hospital
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 days2 otherwise it will be performed 1 hour after examination We plan to enroll 100 patients for this study We will apply McNamers 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
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 days2 otherwise it will be performed 1 hour after examination We plan to enroll 100 patients for this study We will apply McNamers 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
Detailed Description:
as brief summary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None