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

Xijing Hospital of Digestive Diseases

Status: Completed

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: sodium thiosulfate solution; Drug: N-acetylcysteine solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04764643

KY20202056-F-1

Details and patient eligibility

About

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 .

Enrollment: 140 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups

sodium thiosulfate solution arm

Active Comparator group

Description:

20ml of 5% sodium thiosulfate solution were prepared with 1g sodium thiosulfate crystal dissolved in normal saline in a 20 ml syringe

Treatment:

Drug: sodium thiosulfate solution

N-acetylcysteine solution arm

Experimental group

Description:

20ml of 3% N-acetylcysteine solution were prepared with one piece of N-acetylcysteine effervescent tablet （ net weight 0.6g ）dissolved in normal saline in a 20 ml syringe

Treatment:

Drug: N-acetylcysteine solution