Esophageal Squamous Cell Carcinoma
Conditions
Keywords
lugol chromoendoscopy, adverse event
Brief summary
Lugol chromoendoscopy is essential in detecting and characterizing squamous cell carcinoma of esophagus. Esophageal irritating symptom has been reported as an common adverse event, which could be alleviated by sodium thiosulfate solutions. However, sodium thiosulfate was not widely available. N-acetylcysteine has been previously used as a mucolytic reagent, we propose that it may also be used to alleviate irritating symptoms caused by Lugo's chromoendoscopy. A prospective, non-inferior, randomized double-blind clinical trial was designed to study the efficacy of N-acetylcysteine solutions in relieving esophageal discomfort .
Interventions
DRUGN-acetylcysteine solution
use N-acetylcysteine solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy
DRUGsodium thiosulfate solution
use sodium thiosulfate solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients at risk of esophageal squamous cell cancer including those over 50 years old, or over 45 years old with family history of esophageal squamous cell cancer; * Patients with suspected esophageal lesions by screening endoscopy; * Patients requiring surveillance after endoscopic resection or radiotherapy for esophageal squamous cell cancer one year later。
Exclusion criteria
* Patients allergic to iodine or with hyperthyroidism; * Patients with advanced esophageal cancer, esophageal varices, esophageal ulcer or other conditions inadvisable for Lugol chromoendoscopy; * Patients with severe gastroesophageal reflux disease or reflux symptoms which may interfered with the outcome measures of current study; * Patients with postoperative esophageal stenosis affecting endoscopic observation; * Patients with serious comorbidities that cannot tolerate un-sedated gastroscopy; * Patients who could not cooperate with the observation including patients with mental disorders, severe neurosis or dysgnosia; * Patients undergoing sedation or general anesthesia during endoscopy. * Patients who do not agree to sign informed consent forms or follow the trial requirement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Visual analogue scale change | 30 minute after endoscopy | Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with symptom | 5 minute or 30 minute or 24 hour after endoscopy | The percentage of patients with symptom after Lugol chromoendoscopy for certain time |
| Neutralization rate | During endoscopy | Neutralizing effect for residual iodine in esophagus and stomach |
| Heart rate variability | 5 minute or 30 minute after endoscopy | the percentage of heart rate change 5 min or 30 min compared to that Before endoscopy |
| Severe discomfort rate | 5 minute or 30 minute after endoscopy | the percentage of patient with Visual analogue scale over 4 |
| exam time | during endoscopy | the time of endoscopy from the beginning of spraying diluted Lugol's solution to end of endoscopy minus time required for biopsy. |
Countries
China
Outcome results
None listed