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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

N-acetylcysteine solution

sodium thiosulfate solution

About this trial

This is an interventional diagnostic trial for Esophageal Squamous Cell Carcinoma focused on measuring lugol chromoendoscopy, adverse event

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Xijing Hospital of Digestive Disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

sodium thiosulfate solution arm

N-acetylcysteine solution arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean Visual analogue scale change

Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy

Secondary Outcome Measures

Rate of patients with symptom

The percentage of patients with symptom after Lugol chromoendoscopy for certain time

Neutralization rate

Neutralizing effect for residual iodine in esophagus and stomach

Heart rate variability

the percentage of heart rate change 5 min or 30 min compared to that Before endoscopy

Severe discomfort rate

the percentage of patient with Visual analogue scale over 4

exam time

the time of endoscopy from the beginning of spraying diluted Lugol's solution to end of endoscopy minus time required for biopsy.

Full Information

NCT ID

NCT04764643

First Posted

February 19, 2021

Last Updated

January 27, 2023

Sponsor

Xijing Hospital of Digestive Diseases

1. Study Identification

Unique Protocol Identification Number

NCT04764643

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

April 30, 2021 (Actual)

Study Completion Date

May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xijing Hospital of Digestive Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma

Keywords

lugol chromoendoscopy, adverse event

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sodium thiosulfate solution arm

Arm Type

Active Comparator

Arm Description

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

Arm Title

N-acetylcysteine solution arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

N-acetylcysteine solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

sodium thiosulfate solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Visual analogue scale change

Description

Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy

Time Frame

30 minute after endoscopy

Secondary Outcome Measure Information:

Title

Rate of patients with symptom

Description

The percentage of patients with symptom after Lugol chromoendoscopy for certain time

Time Frame

5 minute or 30 minute or 24 hour after endoscopy

Title

Neutralization rate

Description

Neutralizing effect for residual iodine in esophagus and stomach

Time Frame

During endoscopy

Title

Heart rate variability

Description

the percentage of heart rate change 5 min or 30 min compared to that Before endoscopy

Time Frame

5 minute or 30 minute after endoscopy

Title

Severe discomfort rate

Description

the percentage of patient with Visual analogue scale over 4

Time Frame

5 minute or 30 minute after endoscopy

Title

exam time

Description

the time of endoscopy from the beginning of spraying diluted Lugol's solution to end of endoscopy minus time required for biopsy.

Time Frame

during endoscopy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaohua Zhu

Organizational Affiliation

Xijing Hospital of Digestive DIsease

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital of Digestive Disease

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

11174292

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.

Results Reference

background

PubMed Identifier

31669091

Citation

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.

Results Reference

background

PubMed Identifier

34371004

Citation

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.

Results Reference

derived

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

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