Early Detection of Head and Neck Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma

Optical Enhancement Endoscopy Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03700398
• Other study ID #: 2017SDU-QILU-06
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: October 2018
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: February 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Optical Enhancement Endoscopy

Intervention

Device:
• first OE
optical enhancement(OE),a kind of electron straining endoscopy
• first WLI
the routine in the clinical practice

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detect rate	the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma	12 months