Back to resultsEarly Detection of Head and Neck Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma
Primary Purpose
Optical Enhancement Endoscopy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
first OE
first WLI
Sponsored by
About this trial
This is an interventional diagnostic trial for Optical Enhancement Endoscopy
Eligibility Criteria
Inclusion Criteria:
- order than 18 years old
- Previous or current histopathological pathology confirmed the presence of esophageal squamous cell carcinoma
Exclusion Criteria:
- Previously confirmed pharynx/oropharyngeal squamous cell carcinoma
- Advanced pharynx/hypopharyngeal squamous cell carcinoma
- Pregnant women and lactating women
- pharyngeal or esophageal stenosis, esophageal varices, or active digestive tract hemorrhage influence the observation or fail to obtain pathological diagnosis
- Previous chemotherapy or radiation therapy affected observation
- Not completed gastroscopy or refused to take biopsy for various reasons
- Mental illnesses such as anxiety and depression affect the endoscopic observation
- Severe systemic disease, can not tolerate gastroscopy
- Refusal to sign informed consent books
Sites / Locations
- Qilu Hospital of Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
first OE
First WLI
Arm Description
Outcomes
Primary Outcome Measures
detect rate
the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma
Secondary Outcome Measures
Full Information
NCT ID
NCT03700398
First Posted
September 23, 2018
Last Updated
October 6, 2018
Sponsor
Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT03700398
Brief Title
Early Detection of Head and Neck Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma
Official Title
Early Detection of Oropharyngeal and Hypopharyngeal Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma by White Light Imaging and Optical Enhancement(OE)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
February 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
the investigators randomly divide the eligible objects into two groups:1. objects in this group will first receive OE endoscopy observation and subsequent white light imaging(WLI) observation during oropharynx and hypopharynx; 2. objects in this group will first receive WLI observation and subsequent OE observation during oropharynx and hypopharynx. Then, the investigators will compare the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma of two groups to find if OE endoscopy can improve the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma in esophageal cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optical Enhancement Endoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
214 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
first OE
Arm Type
Experimental
Arm Title
First WLI
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
first OE
Intervention Description
optical enhancement(OE)，a kind of electron straining endoscopy
Intervention Type
Device
Intervention Name(s)
first WLI
Intervention Description
the routine in the clinical practice
Primary Outcome Measure Information:
Title
detect rate
Description
the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
order than 18 years old
Previous or current histopathological pathology confirmed the presence of esophageal squamous cell carcinoma
Exclusion Criteria:
Previously confirmed pharynx/oropharyngeal squamous cell carcinoma
Advanced pharynx/hypopharyngeal squamous cell carcinoma
Pregnant women and lactating women
pharyngeal or esophageal stenosis, esophageal varices, or active digestive tract hemorrhage influence the observation or fail to obtain pathological diagnosis
Previous chemotherapy or radiation therapy affected observation
Not completed gastroscopy or refused to take biopsy for various reasons
Mental illnesses such as anxiety and depression affect the endoscopic observation
Severe systemic disease, can not tolerate gastroscopy
Refusal to sign informed consent books
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PHD
Phone
86-531-82169236
Email
liyanqing@sdu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Early Detection of Head and Neck Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma
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