Back to resultsPronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer
Primary Purpose
Esophageal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pronase
Control
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Neoplasms focused on measuring Esophageal Neoplasms, Lugol's solution, Pronase, Endoscopy, Digestive System, Pretreatment method
Eligibility 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.
Sites / Locations
- Xijing Hospital of Digestive Disease
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Pronase
control
Arm Description
Add pronase 20000 U in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.
No pronase in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.
Outcomes
Primary Outcome Measures
Detection rate of high grade dysplasia and carcinoma in iodine void lesion
Detection Rate=（lesions with confirmed high grade dysplasia/all iodine void lesions）*100%
Secondary Outcome Measures
Average Esophageal Visibility Score Before iodine staining
Average Esophageal Visibility Score After iodine staining
Detection Rate of lesions with pink sign
overall detection rate of iodine void lesion
Full Information
NCT ID
NCT02030769
First Posted
January 6, 2014
Last Updated
March 28, 2016
Sponsor
Xijing Hospital of Digestive Diseases
Collaborators
Beijing Tide Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02030769
Brief Title
Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer
Official Title
Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases
Collaborators
Beijing Tide Pharmaceutical Co., Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms
Keywords
Esophageal Neoplasms, Lugol's solution, Pronase, Endoscopy, Digestive System, Pretreatment method
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pronase
Arm Type
Experimental
Arm Description
Add pronase 20000 U in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.
Arm Title
control
Arm Type
Sham Comparator
Arm Description
No pronase in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.
Intervention Type
Drug
Intervention Name(s)
Pronase
Intervention Description
use pronase to improve visibility during endoscopical iodine staining
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining
Primary Outcome Measure Information:
Title
Detection rate of high grade dysplasia and carcinoma in iodine void lesion
Description
Detection Rate=（lesions with confirmed high grade dysplasia/all iodine void lesions）*100%
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Average Esophageal Visibility Score Before iodine staining
Time Frame
30 min after ingesting pretreatment solution
Title
Average Esophageal Visibility Score After iodine staining
Time Frame
within 5 min after iodine staining
Title
Detection Rate of lesions with pink sign
Time Frame
within 5 min after iodine staining
Title
overall detection rate of iodine void lesion
Time Frame
within 5 min after iodine staining
Other Pre-specified Outcome Measures:
Title
observation time for esophagus
Time Frame
with 30 min after intubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaichun Wu, Ph.D. & M.D.
Organizational Affiliation
Xijing Hospital of Digestive DIsease
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital of Digestive Disease
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22267978
Citation
Lopes AB, Fagundes RB. Esophageal squamous cell carcinoma - precursor lesions and early diagnosis. World J Gastrointest Endosc. 2012 Jan 16;4(1):9-16. doi: 10.4253/wjge.v4.i1.9.
Results Reference
background
PubMed Identifier
21796615
Citation
Yokoyama A, Hirota T, Omori T, Yokoyama T, Kawakubo H, Matsui T, Mizukami T, Mori S, Sugiura H, Maruyama K. Development of squamous neoplasia in esophageal iodine-unstained lesions and the alcohol and aldehyde dehydrogenase genotypes of Japanese alcoholic men. Int J Cancer. 2012 Jun 15;130(12):2949-60. doi: 10.1002/ijc.26296. Epub 2011 Sep 16.
Results Reference
background
PubMed Identifier
16874909
Citation
Dubuc J, Legoux J-, Winnock M, Seyrig J-, Barbier J-, Barrioz T, Laugier R, Boulay G, Grasset D, Sautereau D, Grigoresco D, Butel J, Scoazec J-, Ponchon T; Societe Francaise d'Endoscopie Digestive. Endoscopic screening for esophageal squamous-cell carcinoma in high-risk patients: a prospective study conducted in 62 French endoscopy centers. Endoscopy. 2006 Jul;38(7):690-5. doi: 10.1055/s-2006-925255.
Results Reference
background
PubMed Identifier
18718584
Citation
Ishihara R, Yamada T, Iishi H, Kato M, Yamamoto S, Yamamoto S, Masuda E, Tatsumi K, Takeuchi Y, Higashino K, Uedo N, Tatsuta M, Ishiguro S. Quantitative analysis of the color change after iodine staining for diagnosing esophageal high-grade intraepithelial neoplasia and invasive cancer. Gastrointest Endosc. 2009 Feb;69(2):213-8. doi: 10.1016/j.gie.2008.04.052. Epub 2008 Aug 20.
Results Reference
background
PubMed Identifier
17573830
Citation
Shimizu Y, Omori T, Yokoyama A, Yoshida T, Hirota J, Ono Y, Yamamoto J, Kato M, Asaka M. Endoscopic diagnosis of early squamous neoplasia of the esophagus with iodine staining: high-grade intra-epithelial neoplasia turns pink within a few minutes. J Gastroenterol Hepatol. 2008 Apr;23(4):546-50. doi: 10.1111/j.1440-1746.2007.04990.x. Epub 2007 Jun 15.
Results Reference
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Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer
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