Lugol's solution staining was regarded as a gold standard to detect early superficial lesion during esophageal cancer screening using endoscopy. However, the sensitivity and specificity were influenced by mucus and food debris of esophagus. Pronase, a kind of protease, was previously shown to improve the visibility of gastrointestinal tract. It's unknown if the pre-treatment with pronase would also improve the quality of iodine staining in esophagus.A randomized double-blind clinical trial was designed to investigate whether or not pronase might improve detection rate of early esophageal lesion, especially high grade dysplasia and early cancer by improving the esophageal visibility.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,000
use pronase to improve visibility during endoscopical iodine staining
No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining
Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, China
Detection rate of high grade dysplasia and carcinoma in iodine void lesion
Detection Rate=(lesions with confirmed high grade dysplasia/all iodine void lesions)\*100%
Time frame: 1 week
Average Esophageal Visibility Score Before iodine staining
Time frame: 30 min after ingesting pretreatment solution
Average Esophageal Visibility Score After iodine staining
Time frame: within 5 min after iodine staining
Detection Rate of lesions with pink sign
Time frame: within 5 min after iodine staining
overall detection rate of iodine void lesion
Time frame: within 5 min after iodine staining
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