Endoscopists'Subjective Assessments, Image Quality of Early Esophageal Squamous Neoplasia
Conditions
Brief 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.
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.
Interventions
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).
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).
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality of Esophageal Lesions | seven months | Evaluated by Image J software (National Institutes of Health) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire of endoscopists' subjective assessments | intraoperative | The picture will be rated for quality according to color contrast of esophageal lesions after iodine sprayed by the endoscopist performing the examination |
| Complete resection/R0 resection rate | 1 month | — |
| Mucosal change of the stomach in white-light endoscopy after Lugol's solution sprayed. | intraoperative | 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. |
| The amount of Lugol's solution | intraoperative | — |
| Severe adverse events (allergic reactions, esophageal burns, spasms and even perforation) | 1 month | — |
Countries
China
Contacts
Primary ContactXiuli Zuo, PhD
Outcome results
None listed