Detection of Early Esophageal Squamous Neoplasia | NCT01909518

Studies
Detection of Early Esophageal Squamous Neoplasia

NCT01909518

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Jul 26, 2013Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Esophageal Squamous Intraepithelial Neoplasia

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Jul 24, 2013

First Submission Date that Met QC Criteria

Jul 24, 2013

First Posted Date

Jul 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2013

Last Update Posted Date

Jul 26, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the present study：

To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia.
To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy

Detailed Description

Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device and has shown its value for diagnosing Barrett's esophagus, colonal polyps and etc. However, none research has focus on early esophageal squamous neoplasia until now. Previous diagnosis of early esophageal neoplasia is based on the lugol staining which is time wasting and have many adverse events.Other researches have suggested virtual chromoendoscopys are beneficial for screening esophageal tumors. Therefore, the aim of the present study is 1.To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia according to the surface maturation scoring(SMS) diagnostic criteria and 2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy(I-SCAN).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pCLE examination		pCLE is used to distinguish the suspected lesions detected by I-SCAN in esophagus

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The diagnostic accuracy of pCLE on early esophageal squamous neoplasia	Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of early esophageal squamous neoplasia by using probe-based confocal laser endomicroscopy	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged between 50 and 80 years old
Patients undergo screening endoscopy or histologically verified esophageal squamous intraepithelial neoplasia before.

Exclusion Criteria:

Advanced esophageal, gastric or duodenal cancer
History of upper GI tract surgery
Coagulopathy or acute GI bleeding
Pregnant or breast-feeding (for females)
Impaired renal function
Allergy to fluorescein sodium
Inability to provide informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yangqing Li, PhD. MD	Contact	86-531-82169236	82169508	liyanqing@sdu.edu.cn

Overall Officials

Name	Affiliation	Role
Yanqing Li, MD. PhD.	Qilu Hospital of Shandong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Qilu Hospital, Shandong University	Recruiting	Jinan	Shandong	250012	China