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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
50
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 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 solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
Qilu Hospital, Shandong University
Jinan, Shandong, China
Image Quality of Esophageal Lesions
Evaluated by Image J software (National Institutes of Health)
Time frame: seven months
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
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.
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.
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
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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 solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).