Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

Conditions
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Esophageal Neoplasms

Intervention / Treatment
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* Drug: Pronase
* Drug: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pronase<br>Add pronase 20000 U in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate. | Drug: Pronase<br>* use pronase to improve visibility during endoscopical iodine staining<br>|
| Sham Comparator: control<br>No pronase in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate. | Drug: Control<br>* No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of high grade dysplasia and carcinoma in iodine void lesion | Detection Rate=（lesions with confirmed high grade dysplasia/all iodine void lesions）*100% | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Esophageal Visibility Score Before iodine staining |  | 30 min after ingesting pretreatment solution | 
| Average Esophageal Visibility Score After iodine staining |  | within 5 min after iodine staining | 
| Detection Rate of lesions with pink sign |  | within 5 min after iodine staining | 
| overall detection rate of iodine void lesion |  | within 5 min after iodine staining | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Neoplasms, Lugol's solution, Pronase, Endoscopy, Digestive System, Pretreatment method