NCT02030769

Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Esophageal Neoplasms

Interventions

Type	Name	Description
DRUG	Pronase	use pronase to improve visibility during endoscopical iodine staining
DRUG	Control	No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-01-09
• Last updated: 2016-03-29

Locations

1 site across 1 country: China