Detection of Early Esophageal Squamous Neoplasia

• Sponsor: Shandong University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01909518
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 39.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Detection of Early Esophageal Squamous Neoplasia by Using Virtual Chromoendoscopy and Probe-based Confocal Laser Endomicroscopy
• Study Start Date: Jul 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
pCLE examination pCLE is used to distinguish the suspected lesions detected by I-SCAN in esophagus

Outcome Measures

Primary Outcome Measures

1. The diagnostic accuracy of pCLE on early esophageal squamous neoplasia [6 month]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong	China	250012

Sponsors and Collaborators

• Shandong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
• ClinicalTrials.gov Identifier: NCT01909518
• Other Study ID Numbers: 2013SDU-QILU-G02
• First Posted: Jul 26, 2013
• Last Update Posted: Jul 26, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Yanqing Li, Vice president of Qilu Hospital, Shandong University: Esophageal Squamous Intraepithelial Neoplasia; surface maturation scoring; probe-based confocal laser endomicroscopy; virtual chromoendoscopy
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jul 26, 2013