Esophageal Squamous Cell CarcinomaNCT04764643
The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy
A study testing N-acetylcysteine solution and sodium thiosulfate solution in people with Esophageal Squamous Cell Carcinoma, run by Xijing Hospital of Digestive Diseases at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- N-acetylcysteine solution and sodium thiosulfate solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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。
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy: a Prospective, Non-inferiority, Randomized Controlled Trial
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
- Being tested
- N-acetylcysteine solution, sodium thiosulfate solution
- Keywords
- lugol chromoendoscopy, adverse event
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteine solutionDrug
use N-acetylcysteine solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy
sodium thiosulfate solutionDrug
use sodium thiosulfate solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: N-acetylcysteine solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Visual analogue scale change
Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy
Measured: 30 minute after endoscopy
Secondary outcomes (5)
Rate of patients with symptom
The percentage of patients with symptom after Lugol chromoendoscopy for certain time
Measured: 5 minute or 30 minute or 24 hour after endoscopy
Neutralization rate
Neutralizing effect for residual iodine in esophagus and stomach
Measured: During endoscopy
Heart rate variability
the percentage of heart rate change 5 min or 30 min compared to that Before endoscopy
Measured: 5 minute or 30 minute after endoscopy
Severe discomfort rate
the percentage of patient with Visual analogue scale over 4
Measured: 5 minute or 30 minute after endoscopy
exam time
the time of endoscopy from the beginning of spraying diluted Lugol's solution to end of endoscopy minus time required for biopsy.
Measured: during endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Feb 2020
- Primary completion30 Apr 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Liu, Xijing Hospital of Digestive Diseases
- Investigators
- Shaohua Zhu, Principal investigator, Xijing Hospital of Digestive DIsease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764643
- Sponsor's protocol ID
- KY20202056-F-1
- Status last verified
- Jan 2023
- First submitted
- 19 Feb 2021
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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. doi: 10.1067/mge.2001.110730.
PubMed 11174292Gotoda 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.
PubMed 31669091Guo 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.
PubMed 34371004
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy: a Prospective, Non-inferiority, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04764643
- Acronym / sponsor ID
- KY20202056-F-1
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- lugol chromoendoscopy, adverse event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium thiosulfate solution arm | Active comparator | Drug: sodium thiosulfate solution20ml of 5% sodium thiosulfate solution were prepared with 1g sodium thiosulfate crystal dissolved in normal saline in a 20 ml syringe |
| N-acetylcysteine solution arm | Experimental | Drug: N-acetylcysteine solution20ml 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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。
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteine solutionuse N-acetylcysteine solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy | Drug | N-acetylcysteine solution arm |
| sodium thiosulfate solutionuse sodium thiosulfate solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy | Drug | sodium thiosulfate solution arm |
Primary outcome
Mean Visual analogue scale change
Time frame: 30 minute after endoscopy
Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy
5 secondary outcomes
Rate of patients with symptom
Time frame: 5 minute or 30 minute or 24 hour after endoscopy
Neutralization rate
Time frame: During endoscopy
Heart rate variability
Time frame: 5 minute or 30 minute after endoscopy
Severe discomfort rate
Time frame: 5 minute or 30 minute after endoscopy
exam time
Time frame: during endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Background: PubMed 11174292Kondo 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.
- Background: PubMed 31669091Gotoda 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.
- Derived from this study: PubMed 34371004Guo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaohua Zhu principal investigator
Xijing Hospital of Digestive DIsease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetylcysteine solution and sodium thiosulfate solution in people with Esophageal Squamous Cell Carcinoma, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Visual analogue scale change (time frame: 30 minute after endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04764643, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.