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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02939066

Enrollment

Registered

2016-10-19

Start date

2016-05-31

Completion date

Unknown

Last updated

2017-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignancy or Benign of Enlarged Lymph Nodes

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The nCLE interpretation criteria for the characterization of malignant lymph nodes	20 months

Countries

China

Contacts

Primary ContactYanqing Li, PhD. MD.

liyanqing@sdu.edu.cn18678827666

Outcome results