Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

Not Applicable

Completed

• Conditions: Esophageal Neoplasms
• Interventions: Drug: Pronase; Drug: Control

• Registration Number: NCT02030769
• Lead Sponsor: Xijing Hospital of Digestive Diseases

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

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pronase	Pronase	Add pronase 20000 U in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.
control	Control	No pronase in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.

Primary Outcome Measures

Name	Time	Method
Detection rate of high grade dysplasia and carcinoma in iodine void lesion	1 week	Detection Rate=（lesions with confirmed high grade dysplasia/all iodine void lesions）\*100%

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xijing Hospital of Digestive Disease; 🇨🇳 Xi'an, Shaanxi, China