early esophageal cancer
Conditions
Interventions
Experimental group (A):Add an appropriate amount of air into iodine solution at standard concentration
Control group (B):standard-concentration iodine solution
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 40 years old; 2.Long-term smokers or heavy drinkers; 3.Residents from areas with high incidence of esophageal cancer; 4.Having a family history of esophageal cancer (affected first-degree relatives); 5.Patients with precancerous lesions detected by previous gastroscopy, including esophageal mucosal hyperplasia, leukoplakia, mottled lesions, Barrett's esophagus and reflux esophagitis; 6.Long-term consumers of scalding hot food, pickled food and moldy food; 7.Patients with upper gastrointestinal symptoms such as dysphagia discomfort and retrosternal discomfort, who are indicated for iodine staining screening after physician evaluation.
Exclusion criteria
Exclusion criteria: 1.Patients with known or suspected allergy to iodine agents, alcohol or anesthetics related to gastroscopy. 2.Patients with acute esophageal lesions such as severe esophageal stricture, esophageal perforation, active bleeding and severe erosion. 3.Patients with absolute contraindications to gastroscopy (severe cardiopulmonary insufficiency, hemodynamic instability, decompensated liver cirrhosis, etc.). 4.Patients with coagulation disorders (prothrombin time prolonged by more than 3 seconds above the upper limit of normal value). 5.Patients with cognitive impairment, mental illness or other conditions unable to cooperate with examination and follow-up. 6.Pregnant or lactating women. 7.Patients with stroke, acute myocardial infarction or unstable angina pectoris within the recent 3 months. 8.Those currently participating in other clinical trials of drugs or medical devices, or under follow-up of other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lodine spray pressure fluctuation range;Dye coverage finish time (seconds);Esophageal mucosal staining uniformity score (0-10 points);Lesion detection status/Minimal lesion detection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total iodine solution consumption (ml);Incidence of adverse events in both groups;Pathological examination of esophageal mucosal biopsy specimens; | — |
Countries
China
Contacts
Public ContactKai Deng
West China Hospital, Sichuan University
Outcome results
None listed