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

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ClinicalTrials.gov Identifier: NCT02939066
Recruitment Status : Unknown
Verified February 2017 by Yanqing Li, Shandong University.
Recruitment status was:  Recruiting
First Posted : October 19, 2016
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

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.

Condition or disease
Malignancy or Benign of Enlarged Lymph Nodes

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017



Primary Outcome Measures :
  1. The nCLE interpretation criteria for the characterization of malignant lymph nodes [ Time Frame: 20 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939066


Contacts
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Contact: Yanqing Li, PhD. MD. 18678827666 liyanqing@sdu.edu.cn

Locations
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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, PhD. MD.    18678827666    liyanqing@sdu.edu.cn   
Sponsors and Collaborators
Shandong University
Investigators
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Study Director: Yanqing Li, PhD. MD. Department of Gastroenterology, Qilu Hospital, Shandong University

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Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT02939066     History of Changes
Other Study ID Numbers: 2016SDU-QILU-22
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Lymphadenopathy
Lymphatic Diseases