drugset / Trial / NCT04764643

The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy

NCT04764643

Completed 140 enrolled Xijing Hospital of Digestive Diseases
RandomizedParallel-groupQuadruple-blindDiagnostic

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 .

Timeline

Start
2020-02-01
Primary completion
2021-04-30
Completion
2021-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 0.6 g
Comparator Sodium Thiosulfate Diagnostic / imaging agent 1 g