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Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

This study has been completed.
Beijing Tide Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Zhiguo Liu, Xijing Hospital of Digestive Diseases Identifier:
First received: January 6, 2014
Last updated: March 28, 2016
Last verified: March 2016
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.

Condition Intervention
Esophageal Neoplasms
Drug: Pronase
Drug: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

Resource links provided by NLM:

Further study details as provided by Zhiguo Liu, Xijing Hospital of Digestive Diseases:

Primary Outcome Measures:
  • 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%

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

Other Outcome Measures:
  • observation time for esophagus [ Time Frame: with 30 min after intubation ]

Enrollment: 1000
Study Start Date: January 2014
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT02030769

China, Shaanxi
Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
Beijing Tide Pharmaceutical Co., Ltd
Study Chair: Kaichun Wu, Ph.D. & M.D. Xijing Hospital of Digestive DIsease
  More Information


Responsible Party: Zhiguo Liu, Associate Professor, Xijing Hospital of Digestive Diseases Identifier: NCT02030769     History of Changes
Other Study ID Numbers: 20130925-4
Study First Received: January 6, 2014
Last Updated: March 28, 2016

Keywords provided by Zhiguo Liu, Xijing Hospital of Digestive Diseases:
Esophageal Neoplasms
Lugol's solution
Endoscopy, Digestive System
Pretreatment method

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases processed this record on May 25, 2017