Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Evaluation of Malignant Lymph Nodes - a Pilot Study

February 14, 2017 updated by: Yanqing Li, Shandong University

Current modalities for lymph node staging in cancer can be limited. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels.This study aimed to evaluate the feasibility of needle-based confocal laser endomicroscopy (nCLE) at the time of endoscopic ultrasound (EUS) and to describe the nCLE features that distinguish between benign and malignant lymph nodes.

Study Overview

Status

Unknown

Conditions

Malignancy or Benign of Enlarged Lymph Nodes

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients undergoing EUS for staging of malignancy or assessment of enlarged lymph nodes will be recruited in this study at Qilu Hospital, Shandong University.

Description

Inclusion Criteria:

patients undergoing EUS for staging of malignancy or assessment of enlarged lymph nodes

Exclusion Criteria:

Patients aged <18 years or >80 years
Known allergy to fluorescein dye
Previous EUS-FNA performed within the past 3 months, and usualcontraindications to EUS-FNA
Pregnancy or breastfeeding
Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The nCLE interpretation criteria for the characterization of malignant lymph nodes Time Frame: 20 months	20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria