Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273384
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-07
Brief Title:
Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Diagnostic Performance of Current Infection Marker CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
CIM
Brief Summary:
The goal of this cross-sectional study is to evaluate the efficacy of current infection marker CIM method for H pylori detection The main questions it aims to answer are
To evaluate the efficacy of CIM method for H pylori detection compared to rapid urease testRUT histopathology polymerase chain reaction PCR and urea breath test UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer and their sensitivity specificity accuracy positive predictive value PPV negative predictive value NPV positive likelihood ratio and negative likelihood ratio
To evaluate the advantages of CIM method for H pylori detection comparing to RUT histopathology PCR and UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer as net reclassification index NRI
To study the associated factors in false negative value of H pylori detection methods with CIM RUT histopathology PCR and UBT
To evaluate the efficacy of CIM method for H pylori detection compared to rapid urease testRUT histopathology polymerase chain reaction PCR and urea breath test UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer and their sensitivity specificity accuracy positive predictive value PPV negative predictive value NPV positive likelihood ratio and negative likelihood ratio
To evaluate the advantages of CIM method for H pylori detection comparing to RUT histopathology PCR and UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer as net reclassification index NRI
To study the associated factors in false negative value of H pylori detection methods with CIM RUT histopathology PCR and UBT
Detailed Description:
Helicobacter pylori H pylori is a Gram-negative bacillus that involves gastric mucosa and was first isolated in 1982 The global prevalence of H pylori infection is about 50 and the prevalence is different in each region of the world The highest prevalence of H pylori infection is up to 701 in Africa but the prevalence in the South-East Asian region varies from 286 to 703 For Thailand the prevalence of H pylori infection was reported approximately 436-640 H pylori infection is also well-known to be associated with gastric cancer Gastric mucosa-associated lymphoid tissue MALT lymphoma and peptic ulcer
Peptic ulcer strongly associates with H pylori infection The global prevalence of H pylori infection is 485-945 and 669-958 in gastric ulcer and duodenal ulcer respectively These data corresponded to the prevalence in Thailand which is 689 and 828 in gastric ulcers and duodenal ulcers respectively Peptic ulcer is also one of the common causes of upper gastrointestinal hemorrhage In contrast H pylori eradication has been shown to reduce the risk of recurrent upper gastrointestinal bleeding
Nowadays there are several tests for H pylori infection including endoscopic-based methods such as rapid urease test RUT histopathology culture and polymerase chain reaction PCR for deoxyribonucleic acid DNA of H pylori detection and non-invasive methods including urea breath test UBT fecal antigen test and serologic test In clinical practice patients under upper gastrointestinal endoscopy with suspicion of H pylori infection are almost always tested with RUT and histopathology Both these methods are simple and available with high sensitivity and specificity that is greater 90 and 95 respectively
Patients presented with upper gastrointestinal bleeding are recommended to be diagnosed and treated with endoscopy if the peptic ulcer including gastric ulcer or duodenal ulcer was found the H pylori infection must be considered to test Blood in the gastric cavity proton pump inhibitor PPI and antibiotic prescription can decrease the sensitivity and specificity of RUT and histopathology Moreover the patients with gastric ulcer and duodenal ulcer should be generally treated with PPI for a total duration of 8 to 12 weeks and 4 to 8 weeks respectively which could affect the accuracy of RUT for H pylori detection Although PCR technique has more than 98 of sensitivity specificity and accuracy it is very expensive test that requires high performance center so PCR test is not always available and not suitable for clinical practice Therefore these limitations can delay the diagnosis of H pylori infection in patients with upper gastrointestinal hemorrhage so the patients are also not treated this infection in timely manner
Serology test for H pylori infection is the test for blood immunoglobulin G IgG detection that has 85 sensitivity and 79 specificity 26 PPI or antibiotic uses and upper gastrointestinal bleeding do not affect to this test so this method might be a better test for H pylori infection than the endoscopic-based tests including RUT or histopathology Currently the immunochromatographic test is a novel method for H pylori infection that identify current infection marker CIM of H pylori It is a simple and rapid test in which the sensitivity and the specificity in general population are 90 - 923 and 89 - 905 respectively However the use of CIM for H pylori infection in patients with upper gastrointestinal hemorrhage from peptic ulcer who are treated with PPI or antibiotic has not been done yet
This study aims to evaluate the efficacy of CIM for H pylori infection test in patients with upper gastrointestinal hemorrhage from peptic ulcer compared to rapid urease test histopathology PCR for H pylori detection and UBT method
Peptic ulcer strongly associates with H pylori infection The global prevalence of H pylori infection is 485-945 and 669-958 in gastric ulcer and duodenal ulcer respectively These data corresponded to the prevalence in Thailand which is 689 and 828 in gastric ulcers and duodenal ulcers respectively Peptic ulcer is also one of the common causes of upper gastrointestinal hemorrhage In contrast H pylori eradication has been shown to reduce the risk of recurrent upper gastrointestinal bleeding
Nowadays there are several tests for H pylori infection including endoscopic-based methods such as rapid urease test RUT histopathology culture and polymerase chain reaction PCR for deoxyribonucleic acid DNA of H pylori detection and non-invasive methods including urea breath test UBT fecal antigen test and serologic test In clinical practice patients under upper gastrointestinal endoscopy with suspicion of H pylori infection are almost always tested with RUT and histopathology Both these methods are simple and available with high sensitivity and specificity that is greater 90 and 95 respectively
Patients presented with upper gastrointestinal bleeding are recommended to be diagnosed and treated with endoscopy if the peptic ulcer including gastric ulcer or duodenal ulcer was found the H pylori infection must be considered to test Blood in the gastric cavity proton pump inhibitor PPI and antibiotic prescription can decrease the sensitivity and specificity of RUT and histopathology Moreover the patients with gastric ulcer and duodenal ulcer should be generally treated with PPI for a total duration of 8 to 12 weeks and 4 to 8 weeks respectively which could affect the accuracy of RUT for H pylori detection Although PCR technique has more than 98 of sensitivity specificity and accuracy it is very expensive test that requires high performance center so PCR test is not always available and not suitable for clinical practice Therefore these limitations can delay the diagnosis of H pylori infection in patients with upper gastrointestinal hemorrhage so the patients are also not treated this infection in timely manner
Serology test for H pylori infection is the test for blood immunoglobulin G IgG detection that has 85 sensitivity and 79 specificity 26 PPI or antibiotic uses and upper gastrointestinal bleeding do not affect to this test so this method might be a better test for H pylori infection than the endoscopic-based tests including RUT or histopathology Currently the immunochromatographic test is a novel method for H pylori infection that identify current infection marker CIM of H pylori It is a simple and rapid test in which the sensitivity and the specificity in general population are 90 - 923 and 89 - 905 respectively However the use of CIM for H pylori infection in patients with upper gastrointestinal hemorrhage from peptic ulcer who are treated with PPI or antibiotic has not been done yet
This study aims to evaluate the efficacy of CIM for H pylori infection test in patients with upper gastrointestinal hemorrhage from peptic ulcer compared to rapid urease test histopathology PCR for H pylori detection and UBT method
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None