The Diagnostic Value of Nitrogen Element (N) in Esophagus Cancer

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Completed

Conditions: Esophageal Cancer

Treatments: Diagnostic Test: The nitrogen isotope

Study type: Observational

Funder types: Other

Identifiers

NCT05494359

Nitrogen element

Details and patient eligibility

About

The purpose of this study is to determine the diagnostic value of various nitrogen isotopes(N) in oral gas for esophagus cancer (ESCA) .

Full description

Less effective diagnostic markers for ESCA can be used in present. Nitrogen elements include a variety of nitrogen isotopes with various mass. Stable nitrogen isotope ratios 15 Nitrogen/14 Nitrogen (15 N/14 N) are of particular advantage to understand the metabolic state of cancer cells, since most biochemical reactions involve transfer of nitrogen. Cancerous cells can recycle metabolic ammonium for their growth . The recycling of this ammonium with a low nitrogen isotope ratio (15 N/14 N) may cause cancer tissue to have lower 15 N/14 N than surrounding healthy tissue, and it could diagnose malignancy as well as an avenue for investigation of cancer metabolism.

However, the relationship and diagnostic value between nitrogen excretion from oral gas and ESCA remains unclear. The purpose of this study is to analyze the diagnostic value of various mass nitrogen isotope excreting for oral gas for ESCA.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Esophageal cancer patient
• Reflux esophagitis patient
• 18-80 years old

Exclusion criteria

• Esophageal or gastric surgery
• History of previous upper abdominal surgery
• History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
• History of other malignant disease within past five years
• History of previous neoadjuvant chemotherapy or radiotherapy
• History of unstable angina or myocardial infarction within past six months
• History of cerebrovascular accident within past six months
• Requirement of simultaneous surgery for other disease
• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by cancer
• Pregnant women or breastfeeding
• Unwillingness or inability to consent for the study
• Severe mental disorder
• Unstable vital signs Coagulation dysfunction (INR>1.5)
• Low peripheral blood platelet or using anti coagulation drugs
• Long-term Chinese medicine treatment of unknown drug nature

Trial design

120 participants in 3 patient groups

ESCA group

Description:

40 patients of ESCA were included through the diagnosis of gastroscopic biopsy positive. Age, gender, esophageal cancer staging, tumor biomarkers and other laboratory test indicators, CT and other imaging examinations results, gastroscope and pathological examinations results have been collected.

Treatment:

Diagnostic Test: The nitrogen isotope

Health control

Description:

40 healthy people who experienced negative gastroscopy and tumor biomarkers were included as healthy control. Age, gender, gastroscope, tumor biomarkers and other laboratory test results have been collected.

Treatment:

Diagnostic Test: The nitrogen isotope

Reflux esophagitis

Description:

40 patients of reflux esophagitis were included. Age, gender, tumor markers and other laboratory test indicators, gastroscope and pathological examinations results have been collected.

Treatment:

Diagnostic Test: The nitrogen isotope