Rapid Diagnostic Technology for AUGIB Based on Analysis of VOCs in Exhaled Breath

NCT06877507 | Not Yet Recruiting

• 2 other identifiers: 302-2025-VOCs82270694
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to develop a non-invasive and rapid diagnostic technology for acute upper gastrointestinal bleeding (AUGIB) by analyzing volatile organic compounds (VOCs) in exhaled breath. Clinically confirmed patients will be divided into three groups (no bleeding, minor bleeding, major bleeding) based on endoscopic findings. VOC profiles will be analyzed to construct a predictive model, validated for sensitivity and specificity (both targets ≥0.7). This approach addresses the limitations of endoscopy in emergency or resource-limited settings, improving diagnostic efficiency and reducing mortality.

Conditions

Volatile Organic Compound; Gastrointestinal Hemorrhage

Keywords

Volatile Organic Compound; Acute Upper Gastrointestinal Bleeding; Exhaled Breath

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the diagnostic model

  targets ≥0.7

  4 months

Secondary Outcomes (2)

• Identification of key VOCs

  4 months

• Differences in VOC concentrations across 3 bleeding severity groups

  4 months

Study Arms (3)

No bleeding

No blood in the upper gastrointestinal tract

Device: Gastroscopy; Diagnostic Test: Gas Chromatography - Mass Spectrometry

Minor bleeding

A little blood in the upper gastrointestinal tract

Device: Gastroscopy; Diagnostic Test: Gas Chromatography - Mass Spectrometry

Major bleeding

Plenty of blood in the upper gastrointestinal tract

Device: Gastroscopy; Diagnostic Test: Gas Chromatography - Mass Spectrometry

Interventions

Gastroscopy DEVICE

Gastroscopy for all included patients

Major bleeding; Minor bleeding; No bleeding

Gas Chromatography - Mass Spectrometry DIAGNOSTIC_TEST

Using a patient's exhaled breath test with Gas Chromatography - Mass Spectrometry

Major bleeding; Minor bleeding; No bleeding

Eligibility Criteria

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

Study Population

Patients requiring endoscopy for suspected AUGIB

You may qualify if:

• Age ≥18 years;
• Clinical suspicion of AUGIB (e.g., hematemesis, melena);
• Fasting ≥4 hours;
• Signed informed consent.

You may not qualify if:

• Severe pulmonary dysfunction or recent lung infection (within 1 week);
• Cardiac/renal failure or disseminated intravascular coagulation;
• Contraindications to endoscopy;
• High-risk conditions (e.g., massive ascites);
• Alcohol consumption within 24 hours;
• Pregnancy.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

exhaled breath

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; 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 Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: March 20, 2025
• Primary Completion: July 20, 2025
• Study Completion: July 20, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03