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

NCT ID: NCT03700398

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-02-01

Brief Summary

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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

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Conditions

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Optical Enhancement Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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first OE

Group Type EXPERIMENTAL

first OE

Intervention Type DEVICE

optical enhancement(OE),a kind of electron straining endoscopy

First WLI

Group Type OTHER

first WLI

Intervention Type DEVICE

the routine in the clinical practice

Interventions

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first OE

optical enhancement(OE),a kind of electron straining endoscopy

Intervention Type DEVICE

first WLI

the routine in the clinical practice

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yanqing Li, PHD

Role: primary

86-531-82169236

Other Identifiers

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2017SDU-QILU-06

Identifier Type: -

Identifier Source: org_study_id

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