Mucosal IrritationPhase 2NCT03180944
Lower Lugol's Solution Concentration on Reducing the Adverse Symptoms of Chromoendoscopy With Iodine Staining
A Phase 2 study testing 1.2% Lugol's solution, 1.0% Lugol's solution and 0.8% Lugol's solution in people with Mucosal Irritation and Image Quality, run by Shandong University at 1 site in China.
Trial summary
This study was to test an optimal concentration of Lugol's solution which can reduce the mucosal irritation and provide high image quality to ensure endoscopy examination by a randomized blinded controlled trial. Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucosal Irritation, Image Quality
- What is being tested?
- 1.2% Lugol's solution, 1.0% Lugol's solution and 0.8% Lugol's solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Dec 2018
- Phase
- Phase 2
- 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 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients in the high-risk population of ESCC;
- or general risk population of ESCC between 40 to 74 years old. Definition of high-risk population of ESCC is list in supporting information33.
Who cannot join
- with obvious abnormalities in stomach, confirmed by either white-light endoscopy (WLE) or pCLE, including gastric cancer, acute erosive and hemorrhagic gastritis, chronic atrophic gastritis, H. pylori infection and severe bile reflux gastritis;
- advanced esophageal carcinoma;
- known esophageal surgery or endoscopic treatment;
- known esophageal radiotherapy or chemotherapy;
- esophageal stenosis;
- food retention;
Show all 12Show fewer
- allergy to iodine or fluorescein sodium;
- hyperthyroid;
- coagulopathy;
- acute bleeding;
- severe organ failure;
- pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
This study was to test an optimal concentration of Lugol's solution which can reduce the mucosal irritation and provide high image quality to ensure endoscopy examination by a randomized blinded controlled trial.
Read the detailed description
It is widely accepted that chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, this modality may cause severe chest pain and discomfort owing to mucosal irritation. The conventional concentration of Lugol's solution is in the range of 1.2% to 2.5% . Image quality can be guaranteed with this range of Lugol's solution. However, lead to retrosternal pain and discomfort, and can even induce erosion or ulceration in the esophagus and stomach. This study was to test whether a lower concentration of Lugol's solution, which has minimal mucosal irritation, can provide satisfied image quality by a randomized blinded controlled trial.
- Conditions
- Mucosal Irritation, Image Quality
- Being tested
- 1.2% Lugol's solution, 1.0% Lugol's solution, 0.8% Lugol's solution, 0.6% Lugol's solution, 0.4% Lugol's solution
- Keywords
- Lugol's solution, esophageal squamous cell cancer, mucosal irritation, image quality
- 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.
1.2% Lugol's solutionDrug
This group patients were given concentrations of 1.2% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
1.0% Lugol's solutionDrug
This group patients were given concentrations of 1.0% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
0.8% Lugol's solutionDrug
This group patients were given concentrations of 0.8% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
0.6% Lugol's solutionDrug
This group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
0.4% Lugol's solutionDrug
This group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
| Study group | Role | What they receive |
|---|---|---|
| 1.2% Lugol's solution | Experimental | This group patients were given concentrations of 1.2% Lugol's solution for chromoendoscopy. Receives: Drug: 1.2% Lugol's solution |
| 1.0% Lugol's solution | Experimental | This group patients were given concentrations of 1.0% Lugol's solution for chromoendoscopy. Receives: Drug: 1.0% Lugol's solution |
| 0.8% Lugol's solution | Experimental | This group patients were given concentrations of 0.8% Lugol's solution for chromoendoscopy. Receives: Drug: 0.8% Lugol's solution |
| 0.6% Lugol's solution | Experimental | This group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy. Receives: Drug: 0.6% Lugol's solution |
| 0.4% Lugol's solution | Experimental | This group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy. Receives: Drug: 0.4% Lugol's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality
Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality.
Measured: intraoperative
Secondary outcomes (5)
Gastric Mucosa Injury
The gastric mucosal injury caused by Lugol's solution is defined as post-staining gastritis score minus pre-staining gastritis score in pCLE. The confocal gastritis was graded 0 to 3,according to pit patterns, capillaries, and fluorescein leakage. A higher score representing more serious injury.
Measured: 1 months
Adverse Events
Both a written and oral form of the Numerical Rating Scale (NRS) was provided to the patients after the endoscopy examination, used for measuring patients' retrosternal pain, retrosternal discomfort, nausea, abdominal discomfort and others. In NRS, 0 is painless, 10 is the most severe pain, less than 4 is mild pain (pain does not affect sleep), 4-6 is moderate pain, and more than 7 is severe pain (pain means unable to sleep or wake up from sleep).
Measured: 24 hours
Severe Adverse Events
Severe adverse events includes allergic reactions, esophageal burns, spasms and even perforation.
Measured: 24 hours
Tolerance
The 4-point scale was used to assess the tolerance of endoscopist to the esophageal spasm caused by Lugol's solution which prevent endoscopy from passing. 1-4 means the resistance as intolerable, tolerable, mild, or non-existing.
Measured: intraoperative
Histology analysis
All specimens were evaluated by two experienced pathologists blind to the groups of the patients. The macroscopic and histologic diagnosis were made based on Paris classification and Vienna classification, respectively.
Measured: 3-5days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 Sep 2017
- Primary completion30 Nov 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mucosal IrritationStudies 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 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180944
- Sponsor's protocol ID
- 2017SDU-QILU-G001
- Status last verified
- Jan 2020
- First submitted
- 4 Jun 2017
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qu JY, Li Y, Liu GQ, Li Z, Zhong N, Zhang MM, Li YY, Yu T, Lu XF, Li LX, Liu H, Qi QQ, Li YQ, Zuo XL. Optimal concentration of Lugol's solution for detecting early esophageal carcinoma: A randomized controlled trial. J Gastroenterol Hepatol. 2023 Jun;38(6):962-969. doi: 10.1111/jgh.16190. Epub 2023 Apr 24.
PubMed 37094943
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Lugol's Solution Concentration on Reducing the Adverse Symptoms of Chromoendoscopy With Iodine Staining
- ClinicalTrials.gov ID
- NCT03180944
- Acronym / sponsor ID
- 2017SDU-QILU-G001
- Conditions
- Mucosal Irritation, Image Quality
- Keywords
- Lugol's solution, esophageal squamous cell cancer, mucosal irritation, image quality
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 8 Jun 2017 (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.
This study was to test an optimal concentration of Lugol's solution which can reduce the mucosal irritation and provide high image quality to ensure endoscopy examination by a randomized blinded controlled trial.
Detailed description
It is widely accepted that chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, this modality may cause severe chest pain and discomfort owing to mucosal irritation. The conventional concentration of Lugol's solution is in the range of 1.2% to 2.5% . Image quality can be guaranteed with this range of Lugol's solution. However, lead to retrosternal pain and discomfort, and can even induce erosion or ulceration in the esophagus and stomach. This study was to test whether a lower concentration of Lugol's solution, which has minimal mucosal irritation, can provide satisfied image quality by a randomized blinded controlled trial.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1.2% Lugol's solution | Experimental | Drug: 1.2% Lugol's solutionThis group patients were given concentrations of 1.2% Lugol's solution for chromoendoscopy. |
| 1.0% Lugol's solution | Experimental | Drug: 1.0% Lugol's solutionThis group patients were given concentrations of 1.0% Lugol's solution for chromoendoscopy. |
| 0.8% Lugol's solution | Experimental | Drug: 0.8% Lugol's solutionThis group patients were given concentrations of 0.8% Lugol's solution for chromoendoscopy. |
| 0.6% Lugol's solution | Experimental | Drug: 0.6% Lugol's solutionThis group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy. |
| 0.4% Lugol's solution | Experimental | Drug: 0.4% Lugol's solutionThis group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients in the high-risk population of ESCC;
- or general risk population of ESCC between 40 to 74 years old. Definition of high-risk population of ESCC is list in supporting information33.
Key exclusion criteria (12 listed)
- with obvious abnormalities in stomach, confirmed by either white-light endoscopy (WLE) or pCLE, including gastric cancer, acute erosive and hemorrhagic gastritis, chronic atrophic gastritis, H. pylori infection and severe bile reflux gastritis;
- advanced esophageal carcinoma;
- known esophageal surgery or endoscopic treatment;
- known esophageal radiotherapy or chemotherapy;
- esophageal stenosis;
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 |
|---|---|---|
| 1.2% Lugol's solutionThis group patients were given concentrations of 1.2% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions. | Drug | 1.2% Lugol's solution |
| 1.0% Lugol's solutionThis group patients were given concentrations of 1.0% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions. | Drug | 1.0% Lugol's solution |
| 0.8% Lugol's solutionThis group patients were given concentrations of 0.8% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions. | Drug | 0.8% Lugol's solution |
| 0.6% Lugol's solutionThis group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions. | Drug | 0.6% Lugol's solution |
| 0.4% Lugol's solutionThis group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions. | Drug | 0.4% Lugol's solution |
Primary outcome
Image Quality
Time frame: intraoperative
Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality.
5 secondary outcomes
Gastric Mucosa Injury
Time frame: 1 months
Adverse Events
Time frame: 24 hours
Severe Adverse Events
Time frame: 24 hours
Tolerance
Time frame: intraoperative
Histology analysis
Time frame: 3-5days
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 10 Jan 2020.
- Derived from this study: PubMed 37094943Qu JY, Li Y, Liu GQ, Li Z, Zhong N, Zhang MM, Li YY, Yu T, Lu XF, Li LX, Liu H, Qi QQ, Li YQ, Zuo XL. Optimal concentration of Lugol's solution for detecting early esophageal carcinoma: A randomized controlled trial. J Gastroenterol Hepatol. 2023 Jun;38(6):962-969. doi: 10.1111/jgh.16190. Epub 2023 Apr 24.
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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.
Xiuli Zuo, PhD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1.2% Lugol's solution, 1.0% Lugol's solution and 0.8% Lugol's solution in people with Mucosal Irritation and Image Quality, run by Shandong University 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 2 inclusion and 12 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 10 Jan 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Image Quality (time frame: intraoperative). 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 NCT03180944, which also lists 1 linked publication.
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 10 Jan 2020.