Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xijing Hospital of Digestive Diseases
• Collaborator: Beijing Tide Pharmaceutical Co., Ltd

Criteria

Inclusion Criteria:

• Patients 60 years to 75 years old

• Patients less than 60 years old, but with one or multiple high risk factors for esophageal cancer including smoking and drinking addiction,family history of esophageal cancer, personal history of esophageal or head and neck malignancies, previous endoscopy documenting iodine void superficial lesion.

Exclusion Criteria:

• Allergy to iodine or any other medicine which used in this trial.

• Previous endoscopy revealing advanced esophageal cancer or other non-superficial lesions.

• Conditions interfering visibility of endoscope including gastrointestinal obstruction and upper gastrointestinal bleeding.

• Anatomic variation by surgery.

• Pregnancy

• Other conditions which investigator consider the patient at high risk for complications.