Image Quality of Early Esophageal Squamous NeoplasiaPhase 4NCT03180970
Different Lugol's Solution Concentration for Image Quality of Esophageal Lesions in Chromoendoscopy With Iodine Staining
A Phase 4 study testing 1.2% Lugol's solution, 1.0% Lugol's solution and 0.8% Lugol's solution in people with Image Quality of Early Esophageal Squamous Neoplasia and Endoscopists'Subjective Assessments, run by Shandong University at 1 site in China.
Trial summary
The purpose of this study is to assess whether lower Lugol's solution concentration can perceive the same image quality of early esophageal squamous neoplasia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Image Quality of Early Esophageal Squamous Neoplasia, Endoscopists'Subjective Assessments
- 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
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jun 2017to Dec 2017
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with early esophageal squamous neoplasia who underwent endoscopic submucosal dissection.
Who cannot join
- After esophageal surgery or endoscopic treatment ; Known esophageal radiotherapy or chemotherapy ; Esophageal stenosis; Acute bleeding; A known allergy to iodine; Coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 seconds); Having food retention; Severe hepatic ,renal, cardiovascular or metabolic dysfunction ; Being pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
China1 site
Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Xiuli Zuo, PhD, 15588818685 ext. 053188369277, zuoxiuli@sina.com
Junyan Qu, MD
About this study
Official title: Different Lugol's Solution Concentration for Image Quality of Early Esophageal Squamous Neoplasia in Chromoendoscopy With Iodine Staining
The purpose of this study is to assess whether lower Lugol's solution concentration can perceive the same image quality of early esophageal squamous neoplasia.
Read the detailed description
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.
This study was to test whether a lower concentration of Lugol's solution can provide satisfied image quality of early esophageal squamous neoplasia and has lower mucosal irritation.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.2% Lugol's solutionDrug
1.2% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
1.0% Lugol's solutionDrug
1.0% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
0.8% Lugol's solutionDrug
0.8% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
0.6% Lugol's solutionDrug
0.6% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
0.4% Lugol's solutionDrug
0.4% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | This group patients were given dosages of 1.2% Lugol's solution for chromoendoscopy. Receives: Drug: 1.2% Lugol's solution |
| group 2 | Experimental | This group patients were given dosages of 1.0% Lugol's solution for chromoendoscopy. Receives: Drug: 1.0% Lugol's solution |
| group 3 | Experimental | This group patients were given dosages of 0.8% Lugol's solution for chromoendoscopy. Receives: Drug: 0.8% Lugol's solution |
| group 4 | Experimental | This group patients were given dosages of 0.6% Lugol's solution for chromoendoscopy. Receives: Drug: 0.6% Lugol's solution |
| group 5 | Experimental | This group patients were given dosages 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 of Esophageal Lesions
Evaluated by Image J software (National Institutes of Health)
Measured: seven months
Secondary outcomes (5)
Questionnaire of endoscopists' subjective assessments
The picture will be rated for quality according to color contrast of esophageal lesions after iodine sprayed by the endoscopist performing the examination
Measured: intraoperative
Complete resection/R0 resection rate
Measured: 1 month
Mucosal change of the stomach in white-light endoscopy after Lugol's solution sprayed.
The endoscopic findings of the greater curvature of the gastric body where the agent collected will be evaluated based on the following findings:fold thickening, exudates, ulcers, and hemorrhage.
Measured: intraoperative
The amount of Lugol's solution
Measured: intraoperative
Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation)
Measured: 1 month
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 startJun 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Image Quality of Early Esophageal Squamous NeoplasiaStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
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
- NCT03180970
- Sponsor's protocol ID
- 2017SDU-QILU-G002
- Status last verified
- Jun 2017
- First submitted
- 4 Jun 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Lugol's Solution Concentration for Image Quality of Early Esophageal Squamous Neoplasia in Chromoendoscopy With Iodine Staining
- ClinicalTrials.gov ID
- NCT03180970
- Acronym / sponsor ID
- 2017SDU-QILU-G002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- 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.
The purpose of this study is to assess whether lower Lugol's solution concentration can perceive the same image quality of early esophageal squamous neoplasia.
Detailed description
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.
This study was to test whether a lower concentration of Lugol's solution can provide satisfied image quality of early esophageal squamous neoplasia and has lower mucosal irritation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: 1.2% Lugol's solutionThis group patients were given dosages of 1.2% Lugol's solution for chromoendoscopy. |
| group 2 | Experimental | Drug: 1.0% Lugol's solutionThis group patients were given dosages of 1.0% Lugol's solution for chromoendoscopy. |
| group 3 | Experimental | Drug: 0.8% Lugol's solutionThis group patients were given dosages of 0.8% Lugol's solution for chromoendoscopy. |
| group 4 | Experimental | Drug: 0.6% Lugol's solutionThis group patients were given dosages of 0.6% Lugol's solution for chromoendoscopy. |
| group 5 | Experimental | Drug: 0.4% Lugol's solutionThis group patients were given dosages of 0.4% Lugol's solution for chromoendoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with early esophageal squamous neoplasia who underwent endoscopic submucosal dissection.
Key exclusion criteria (1 listed)
- After esophageal surgery or endoscopic treatment ; Known esophageal radiotherapy or chemotherapy ; Esophageal stenosis; Acute bleeding; A known allergy to iodine; Coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 seconds); Having food retention; Severe hepatic ,renal, cardiovascular or metabolic dysfunction ; Being pregnant or lactating.
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 solution1.2% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD). | Drug | group 1 |
| 1.0% Lugol's solution1.0% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD). | Drug | group 2 |
| 0.8% Lugol's solution0.8% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD). | Drug | group 3 |
| 0.6% Lugol's solution0.6% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD). | Drug | group 4 |
| 0.4% Lugol's solution0.4% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD). | Drug | group 5 |
Primary outcome
Image Quality of Esophageal Lesions
Time frame: seven months
Evaluated by Image J software (National Institutes of Health)
5 secondary outcomes
Questionnaire of endoscopists' subjective assessments
Time frame: intraoperative
Complete resection/R0 resection rate
Time frame: 1 month
Mucosal change of the stomach in white-light endoscopy after Lugol's solution sprayed.
Time frame: intraoperative
The amount of Lugol's solution
Time frame: intraoperative
Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
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 4 study testing 1.2% Lugol's solution, 1.0% Lugol's solution and 0.8% Lugol's solution in people with Image Quality of Early Esophageal Squamous Neoplasia and Endoscopists'Subjective Assessments, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jun 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Zuo, PhD (15588818685 ext. 053188369277, zuoxiuli@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality of Esophageal Lesions (time frame: seven months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2017.