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Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

NCT02030769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2016-03-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Beijing Tide Pharmaceutical Co., Ltd

    collaborator INDUSTRY

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Principal Investigators

  • Kaichun Wu, Ph.D. & M.D. · Xijing Hospital of Digestive DIsease

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02030769 on ClinicalTrials.gov