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

Not Applicable

• Conditions: Optical Enhancement Endoscopy
• Interventions: Device: first WLI; Device: first OE

• Registration Number: NCT03700398
• Lead Sponsor: Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-09-23
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-06
• Last Update Submitted: 2018-10-06
• Study First Posted: 2018-10-09
• Last Update Posted: 2018-10-09
• Primary Completion: 2019-01-01
• Study Completion: 2019-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• order than 18 years old
• Previous or current histopathological pathology confirmed the presence of esophageal squamous cell carcinoma

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
First WLI	first WLI	-
first OE	first OE	-

Primary Outcome Measures

Name	Time	Method
detect rate	12 months	the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China