Volatile Organic Compounds (VOCs) of Exhaled Breath in Patients With GI Bleeding

NCT04226079 | Unknown

• 1 other identifier: 1911-086-107
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cross sectional case-control study investigating the difference of volatile organic compound in the exhaled breath of the patients with GI bleeding and normal population.

Conditions

Gastrointestinal Hemorrhage; Volatile Organic Compounds

Outcome Measures

Primary Outcomes (1)

• VOC Patterns

  Patterns of volatile organic compounds recognized by sensor array

  1 day of 1st emergency room (ER) visit for GI bleeding

Secondary Outcomes (2)

• Measurement of VOC

  1 day of 1st emergency room (ER) visit for GI bleeding

• Change of VOC patterns

  2nd visit (about 2weeks apart from 1st visit)

Study Arms (2)

Normal control

Normal population with low prevalence of gastrointestinal bleeding who underwent EGD and CFS which revealed no abnormal finding.

Diagnostic Test: Collection of exhaled breath

Patients with GI bleeding

Patients who visited emergency room and were highly suspected to have recent or active upper GI bleeding and scheduled for upper GI endoscopy.

Diagnostic Test: Collection of exhaled breath

Interventions

Collection of exhaled breath DIAGNOSTIC_TEST

Collection of exhaled breath will be analyzed for specific volatile organic compounds which show different distribution between groups

Normal control; Patients with GI bleeding

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inclusion Criteria: * Adults aged 20-80 * Patients who visited emergency room and suspected to have recent or active gastrointestinal bleeding * Patients who are scheduled to undergo esophagogastroduodenoscopy. Exclusion Criteria: * Diagnosis of malignancy diagnosed within 5 years * Past medical history of chronic liver disease, chronic kidney disease, chronic lung disease, chronic bronchial disease, asthma * Surgical history of any kind of gastrectomy * Surgical history of any kind of lung resection which could impact the patient's lung function.

You may qualify if:

• Adults aged between 20 and 80
• Low possibility of gastrointestinal bleeding was proven by esophagogastroduodenoscopy and colonoscopy which were performed within 1 year.

You may not qualify if:

• Diagnosis of malignancy diagnosed within 5 years
• Past medical history of chronic liver disease, chronic kidney disease, chronic lung disease, chronic bronchial disease, asthma
• Surgical history of any kind of gastrectomy
• Surgical history of any kind of lung resection which could impact the patient's lung function.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Jin Ju Choi

Seoul, Gyunggi-do, 02830, South Korea

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• HYUNSOO CHUNG, M.D.

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

JIN JU CHOI, M.D.

CONTACT

01028087284; wallet87@hanmail.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: January 1, 2020
• Primary Completion: April 1, 2020
• Study Completion: July 1, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

KR (1)