NCT03700398

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

September 23, 2018

Last Update Submit

October 6, 2018

Conditions

Optical Enhancement Endoscopy

Outcome Measures

Primary Outcomes (1)

  • detect rate

    the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma

    12 months

Study Arms (2)

first OE

EXPERIMENTAL
Device: first OE

First WLI

OTHER
Device: first WLI

Interventions

first OEDEVICE

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

first OE
first WLIDEVICE

the routine in the clinical practice

First WLI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of Qilu Hospital

Study Record Dates

First Submitted

September 23, 2018

First Posted

October 9, 2018

Study Start

October 1, 2017

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

CN(1)