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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04764643

Recruitment Status : Recruiting

First Posted : February 21, 2021

Last Update Posted : February 21, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Zhiguo Liu, Xijing Hospital of Digestive Diseases

Study Description

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 .

Condition or disease	Intervention/treatment	Phase
Esophageal Squamous Cell Carcinoma	Drug: N-acetylcysteine solution Drug: sodium thiosulfate solution	Not Applicable

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	140 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Diagnostic
Official Title:	The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy: a Prospective, Non-inferiority, Randomized Controlled Trial
Actual Study Start Date :	February 1, 2020
Estimated Primary Completion Date :	April 30, 2021
Estimated Study Completion Date :	May 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Acetylcysteine Sodium thiosulfate Potassium triiodide

Genetic and Rare Diseases Information Center resources: Esophageal Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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	Drug: sodium thiosulfate solution use sodium thiosulfate solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy
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	Drug: N-acetylcysteine solution use N-acetylcysteine solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome 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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04764643

Contacts

Layout table for location contacts

Contact: Shaohua Zhu	8613991269434	sheng2002@163.com

Locations

Layout table for location information

China, Shaanxi
Xijing Hospital of Digestive Disease	Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Shaohua Zhu 8613991269434 sheng2002@163.com

Sponsors and Collaborators

Xijing Hospital of Digestive Diseases

Investigators

Layout table for investigator information

Principal Investigator:	Shaohua Zhu	Xijing Hospital of Digestive DIsease

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	Zhiguo Liu, associate professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier:	NCT04764643
Other Study ID Numbers:	KY20202056-F-1
First Posted:	February 21, 2021 Key Record Dates
Last Update Posted:	February 21, 2021
Last Verified:	February 2021

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Zhiguo Liu, Xijing Hospital of Digestive Diseases:


lugol chromoendoscopy adverse event

Additional relevant MeSH terms:

Layout table for MeSH terms

Esophageal Squamous Cell Carcinoma 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	Acetylcysteine Sodium thiosulfate Pharmaceutical Solutions N-monoacetylcystine Antiviral Agents Anti-Infective Agents Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes Antitubercular Agents

To Top