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

NCT04764643 | Completed DMC

• 1 other identifier: KY20202056-F-1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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 .

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

lugol chromoendoscopy; adverse event

Outcome Measures

Primary Outcomes (1)

• Mean Visual analogue scale change

  Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy

  30 minute after endoscopy

Secondary Outcomes (5)

• Rate of patients with symptom

  5 minute or 30 minute or 24 hour after endoscopy

• Neutralization rate

  During endoscopy

• Heart rate variability

  5 minute or 30 minute after endoscopy

• Severe discomfort rate

  5 minute or 30 minute after endoscopy

• exam time

  during endoscopy

Study Arms (2)

sodium thiosulfate solution arm

ACTIVE COMPARATOR

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

Drug: sodium thiosulfate solution

N-acetylcysteine solution arm

EXPERIMENTAL

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

Drug: N-acetylcysteine solution

Interventions

N-acetylcysteine solution DRUG

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

N-acetylcysteine solution arm

sodium thiosulfate solution DRUG

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

sodium thiosulfate solution arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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。

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Related Publications (3)

• 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.

  PMID: 11174292 BACKGROUND

• 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.

  PMID: 31669091 BACKGROUND

• Guo Q, Fan X, Zhu S, Zhao X, Fang N, Guo M, Liu Z, Han Y. Comparing N-acetylcysteine with sodium thiosulfate for relieving symptoms caused by Lugol's iodine chromoendoscopy: a randomized, double-blind trial. Gastrointest Endosc. 2022 Feb;95(2):249-257. doi: 10.1016/j.gie.2021.07.025. Epub 2021 Aug 8.

  PMID: 34371004 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Shaohua Zhu

  Xijing Hospital of Digestive DIsease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 21, 2021
• Study Start: February 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 31, 2021
• Last Updated: January 30, 2023

Record last verified: 2023-01

Locations

CN (1)