Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

Xijing Hospital of Digestive Diseases

Status

Completed

Conditions

Esophageal Neoplasms

Treatments

Drug: Pronase

Drug: Control

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02030769

20130925-4

Details and patient eligibility

About

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.

Enrollment

1,000 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.