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

Not Applicable

Completed

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: sodium thiosulfate solution; Drug: N-acetylcysteine solution

• Registration Number: NCT04764643
• Lead Sponsor: Xijing Hospital of Digestive Diseases

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-21
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sodium thiosulfate solution arm	sodium thiosulfate solution	20ml of 5% sodium thiosulfate solution were prepared with 1g sodium thiosulfate crystal dissolved in normal saline in a 20 ml syringe
N-acetylcysteine solution arm	N-acetylcysteine solution	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

Primary Outcome Measures

Name	Time	Method
Mean Visual analogue scale change	30 minute after endoscopy	Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy

Secondary Outcome Measures

Name	Time	Method
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
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.
Neutralization rate	During endoscopy	Neutralizing effect for residual iodine in esophagus and stomach
Severe discomfort rate	5 minute or 30 minute after endoscopy	the percentage of patient with Visual analogue scale over 4
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

Trial Locations

Locations (1)

Xijing Hospital of Digestive Disease; 🇨🇳 Xi'an, Shaanxi, China