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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

sodium thiosulfate solution

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

N-acetylcysteine solution

Intervention Type DRUG

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

Interventions

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N-acetylcysteine solution

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

Intervention Type DRUG

sodium thiosulfate solution

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes