Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | This group patients were given dosages of 1.2% Lugol's solution for chromoendoscopy. |
|
| group 2 | Experimental | This group patients were given dosages of 1.0% Lugol's solution for chromoendoscopy. |
|
| group 3 | Experimental | This group patients were given dosages of 0.8% Lugol's solution for chromoendoscopy. |
|
| group 4 | Experimental | This group patients were given dosages of 0.6% Lugol's solution for chromoendoscopy. |
|
| group 5 | Experimental | This group patients were given dosages of 0.4% Lugol's solution for chromoendoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.2% Lugol's solution | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality of Esophageal Lesions | Evaluated by Image J software (National Institutes of Health) | seven months |
| 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 |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiuli Zuo, PhD | Contact | 15588818685 | 053188369277 | zuoxiuli@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiuli Zuo, PhD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital, Shandong University | Jinan | Shandong | 250012 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| 1.0% Lugol's solution | Drug | 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 | Drug | 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 | Drug | 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 | Drug | 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). |
|
| 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 |
| ID | Term |
|---|---|
| C010389 | Lugol's solution |
Not provided
Not provided
Not provided