Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
Study NCT ID:
NCT02030769
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2014-01-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer
Sponsor:
Xijing Hospital of Digestive Diseases
Organization:
Study Overview
Official Title:
Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: