Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Lugol's solution, staining sequence, Esophageal Squamous Cell Carcinoma, Effectiveness, Safety
Brief summary
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
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.
Interventions
PROCEDUREstaining from cervical esophagus to esophagogastric junction
This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy.
PROCEDUREstaining from esophagogastric junction to cervical esophagus
This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy.
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality | intraoperative | Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 24 hours | Adverse events of the two groups. |
| Dose | intraoperative | Usage of Lugol's solution in each group. |
| Effectiveness | 1 month | Detection rate of esophageal squamous cell carcinoma of the two groups. |
| Tolerance | intraoperative | 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. |
Contacts
Primary ContactXiuli Zuo, MD,PhD
Outcome results
None listed