Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding

NCT06273384 | Not Yet Recruiting

• 1 other identifier: Si 062/2023
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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 test(RUT), 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.

Conditions

Helicobacter Pylori Infection; Peptic Ulcer Hemorrhage

Keywords

Helicobacter Pylori Infection; Peptic Ulcer Hemorrhage; Current infection marker

Outcome Measures

Primary Outcomes (1)

• The efficacy of CIM method for H. pylori detection

  The sensitivity, specificity, and accuracy of the CIM method for H. pylori detection were compared to those of RUT, histopathology, PCR, and UBT.

  Through study completion, an average of 2 years

Secondary Outcomes (1)

• The advantages of CIM method for H. pylori detection

  Through study completion, an average of 2 years

Study Arms (1)

Intervention group

Patients aged 18 years and older who present with peptic ulcer hemorrhage, confirmed by esophagogastroduodenoscopy (EGD).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 years or older, who present with upper gastrointestinal hemorrhage and undergo esophagogastroduodenoscopy, receiving a diagnosis of peptic ulcer, will be recruited and enrolled. The exclusion criteria include patients with inappropriate gastric mucosal biopsy conditions, such as hemodynamic instability, coagulopathy, severe thrombocytopenia, or the presence of massive bloody content in the gastric cavity or duodenum. Additionally, individuals with a previous history of gastric surgery, such as partial or total gastrectomy, will be excluded.

You may qualify if:

• Age ≥ 18 years
• Upper gastrointestinal hemorrhage and undergo esophagogastroduodenoscopy with diagnosis of peptic ulcer

You may not qualify if:

• Inappropriate gastric mucosal biopsy conditions such as hemodynamic instability, coagulopathy or severe thrombocytopenia or massive bloody content in gastric cavity or duodenum
• Previous history of gastric surgery such as partial or total gastrectomy

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

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Biospecimen

Retention: SAMPLES WITH DNA

Participants underwent esophagogastroduodenoscopy (EGD) with random biopsies of two pieces of gastric mucosa: one from the antrum and another from the incisura angularis. Subsequently, PCR was performed for the detection of H. pylori DNA.

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Monthira Maneerattanaporn, Asso Prof

  Department of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanapat Atthakitmongkol, MD

CONTACT

66813998583; ben02170@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 22, 2024
• Study Start: March 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)