Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

March 28, 2016 updated by: Zhiguo Liu, Xijing Hospital of Digestive Diseases
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital of Digestive Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
observation time for esophagus
Time Frame: with 30 min after intubation
with 30 min after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital of Digestive Diseases

Collaborators

Beijing Tide Pharmaceutical Co., Ltd

Investigators

  • Study Chair: Kaichun Wu, Ph.D. & M.D., Xijing Hospital of Digestive Disease

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130925-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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