Detection of Early Esophageal Squamous Neoplasia

Detection of Early Esophageal Squamous Neoplasia by Using Virtual Chromoendoscopy and Probe-based Confocal Laser Endomicroscopy

The aim of the present study：

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

Study Overview

• Status: Unknown
• Conditions: Esophageal Squamous Intraepithelial Neoplasia

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).

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Yangqing li, PhD. MD; Phone Number: 82169508 86-531-82169236; Email: liyanqing@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
pCLE examination; pCLE is used to distinguish the suspected lesions detected by I-SCAN in esophagus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Yanqing Li, MD. PhD., Qilu Hospital, Shandong University

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (ESTIMATE): July 26, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 26, 2013
• Last Update Submitted That Met QC Criteria: July 24, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: virtual chromoendoscopy; probe-based confocal laser endomicroscopy; Esophageal Squamous Intraepithelial Neoplasia; surface maturation scoring
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2013SDU-QILU-G02