Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-12-31

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.

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Detailed Description

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Conditions

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Esophageal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pronase

Add pronase 20000 U in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.

Group Type EXPERIMENTAL

Pronase

Intervention Type DRUG

use pronase to improve visibility during endoscopical iodine staining

control

No pronase in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.

Group Type SHAM_COMPARATOR

Control

Intervention Type DRUG

No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining

Interventions

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Pronase

use pronase to improve visibility during endoscopical iodine staining

Intervention Type DRUG

Control

No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes