Different Lugol's Solution Concentration for Image Quality of Esophageal Lesions in Chromoendoscopy With Iodine Staining

Study Overview
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Brief Summary
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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
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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.

Official Title
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Different Lugol's Solution Concentration for Image Quality of Early Esophageal Squamous Neoplasia in Chromoendoscopy With Iodine Staining

Conditions
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Image Quality of Early Esophageal Squamous Neoplasia, Endoscopists'Subjective Assessments

Intervention / Treatment
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* Drug: 1.2% Lugol's solution
* Drug: 1.0% Lugol's solution
* Drug: 0.8% Lugol's solution
* Drug: 0.6% Lugol's solution
* Drug: 0.4% Lugol's solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with early esophageal squamous neoplasia who underwent endoscopic submucosal dissection. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>This group patients were given dosages of 1.2% Lugol's solution for chromoendoscopy. | Drug: 1.2% Lugol's solution<br>* 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).<br>|
| Experimental: group 2<br>This group patients were given dosages of 1.0% Lugol's solution for chromoendoscopy. | Drug: 1.0% Lugol's solution<br>* 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).<br>|
| Experimental: group 3<br>This group patients were given dosages of 0.8% Lugol's solution for chromoendoscopy. | Drug: 0.8% Lugol's solution<br>* 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).<br>|
| Experimental: group 4<br>This group patients were given dosages of 0.6% Lugol's solution for chromoendoscopy. | Drug: 0.6% Lugol's solution<br>* 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).<br>|
| Experimental: group 5<br>This group patients were given dosages of 0.4% Lugol's solution for chromoendoscopy. | Drug: 0.4% Lugol's solution<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality of Esophageal Lesions | Evaluated by Image J software (National Institutes of Health) | seven months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | intraoperative | 
| Complete resection/R0 resection rate |  | 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. | intraoperative | 
| The amount of Lugol's solution |  | intraoperative | 
| Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation) |  | 1 month |