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

Overview

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 .

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2021

Interventions

  • Drug: N-acetylcysteine solution
    • use N-acetylcysteine solution to alleviate esophageal irritation caused by Lugol’s chromoendoscopy
  • Drug: sodium thiosulfate solution
    • use sodium thiosulfate solution to alleviate esophageal irritation caused by Lugol’s chromoendoscopy

Arms, Groups and Cohorts

  • Active Comparator: sodium thiosulfate solution arm
    • 20ml of 5% sodium thiosulfate solution were prepared with 1g sodium thiosulfate crystal dissolved in normal saline in a 20 ml syringe
  • Experimental: N-acetylcysteine solution arm
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Mean Visual analogue scale change
    • Time Frame: 30 minute after endoscopy
    • Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Xijing Hospital of Digestive Diseases
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhiguo Liu, associate professor – Xijing Hospital of Digestive Diseases
  • Overall Official(s)
    • Shaohua Zhu, Principal Investigator, Xijing Hospital of Digestive DIsease

References

Kondo H, Fukuda H, Ono H, Gotoda T, Saito D, Takahiro K, Shirao K, Yamaguchi H, Yoshida S. Sodium thiosulfate solution spray for relief of irritation caused by Lugol's stain in chromoendoscopy. Gastrointest Endosc. 2001 Feb;53(2):199-202. doi: 10.1067/mge.2001.110730.

Gotoda T, Kanzaki H, Okamoto Y, Obayashi Y, Baba Y, Hamada K, Sakae H, Abe M, Iwamuro M, Kawano S, Kawahara Y, Okada H. Tolerability and efficacy of the concentration of iodine solution during esophageal chromoendoscopy: a double-blind randomized controlled trial. Gastrointest Endosc. 2020 Apr;91(4):763-770. doi: 10.1016/j.gie.2019.10.022. Epub 2019 Oct 25.

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