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Completed

NCT Number: NCT04764643

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

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 .

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Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetylcysteine solution

Drug

use N-acetylcysteine solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy

sodium thiosulfate solution

Drug

use sodium thiosulfate solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy

Primary outcomes

  1. Mean Visual analogue scale change

    Time frame: 30 minute after endoscopy

    Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy

Secondary outcomes

  1. Rate of patients with symptom

    Time frame: 5 minute or 30 minute or 24 hour after endoscopy

    The percentage of patients with symptom after Lugol chromoendoscopy for certain time

  2. Neutralization rate

    Time frame: During endoscopy

    Neutralizing effect for residual iodine in esophagus and stomach

  3. Heart rate variability

    Time frame: 5 minute or 30 minute after endoscopy

    the percentage of heart rate change 5 min or 30 min compared to that Before endoscopy

  4. Severe discomfort rate

    Time frame: 5 minute or 30 minute after endoscopy

    the percentage of patient with Visual analogue scale over 4

  5. exam time

    Time frame: during endoscopy

    the time of endoscopy from the beginning of spraying diluted Lugol's solution to end of endoscopy minus time required for biopsy.

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy: a Prospective, Non-inferiority, Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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