Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Xijing Hospital of Digestive Diseases
Sponsor:
Collaborator:
Beijing Tide Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Zhiguo Liu, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier:
NCT02030769
First received: January 6, 2014
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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 No pronase plus Dimethicone and sodium bicarbonate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Detection rate of high grade dysplasia and carcinoma in iodine void lesion [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Average Esophageal Visibility Score After iodine staining [ Time Frame: within 5 min after iodine staining ] [ Designated as safety issue: No ]
  • Detection Rate of lesions with pink sign [ Time Frame: within 5 min after iodine staining ] [ Designated as safety issue: No ]
  • overall detection rate of iodine void lesion [ Time Frame: within 5 min after iodine staining ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • observation time for esophagus [ Time Frame: with 30 min after intubation ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: January 2014
Estimated Study Completion Date: March 2015
Estimated 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
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030769

Contacts
Contact: Zhiguo liu 8613892812764 liuzhiguo@fmmu.edu.cn
Contact: Kaichun Wu

Locations
China, Shaanxi
Xijing Hospital of Digestive Disease Recruiting
Xi'an, Shaanxi, China, 710032
Contact: zhiguo liu    8613892812764    liuzhiguo@fmmu.edu.cn   
Sub-Investigator: Zhiguo Liu         
Principal Investigator: Kaichun Wu         
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
Beijing Tide Pharmaceutical Co., Ltd
Investigators
Study Chair: Kaichun Wu, Ph.D. & M.D. Xijing Hospital of Digestive DIsease
  More Information

Publications:

Responsible Party: Zhiguo Liu, Associate Professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT02030769     History of Changes
Other Study ID Numbers: 20130925-4
Study First Received: January 6, 2014
Last Updated: January 8, 2014
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014