Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction

Study Overview
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Brief Summary
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The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.

Detailed Description
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Chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, there is no study to investigate the sequence of Lugol's staining during endoscopic procedure. The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.

Official Title
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Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Procedure: staining from cervical esophagus to esophagogastric junction
* Procedure: staining from esophagogastric junction to cervical esophagus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High risk patients of early esophageal squamous neoplasias. 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Downward Staining<br>This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy. | Procedure: staining from cervical esophagus to esophagogastric junction<br>* This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy.<br>|
| Experimental: Upward Staining<br>This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy. | Procedure: staining from esophagogastric junction to cervical esophagus<br>* This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality | Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events of the two groups. | 24 hours | 
| Dose | Usage of Lugol's solution in each group. | intraoperative | 
| Effectiveness | Detection rate of esophageal squamous cell carcinoma of the two groups. | 1 month | 
| 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. | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Lugol's solution, staining sequence, Esophageal Squamous Cell Carcinoma, Effectiveness