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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764643
• Other study ID #: KY20202056-F-1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: January 2023
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Disease	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Visual analogue scale change	Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy	30 minute after endoscopy
Secondary	Rate of patients with symptom	The percentage of patients with symptom after Lugol chromoendoscopy for certain time	5 minute or 30 minute or 24 hour after endoscopy
Secondary	Neutralization rate	Neutralizing effect for residual iodine in esophagus and stomach	During endoscopy
Secondary	Heart rate variability	the percentage of heart rate change 5 min or 30 min compared to that Before endoscopy	5 minute or 30 minute after endoscopy
Secondary	Severe discomfort rate	the percentage of patient with Visual analogue scale over 4	5 minute or 30 minute after endoscopy
Secondary	exam time	the time of endoscopy from the beginning of spraying diluted Lugol's solution to end of endoscopy minus time required for biopsy.	during endoscopy