EUS-FNA for Retropharyngeal Lymph Node (RPLN) in Recurrent Nasopharyngeal Carcinoma (NPC) Patients

December 29, 2016 updated by: Jian-jun Li, Sun Yat-sen University

Fine Needle Aspiration of Retropharyngeal Lymph Node Guided by Endoscopic Ultrasound for the Diagnosis of Patients With Suspected Recurrent Nasopharyngeal Carcinoma

EUS-FNA for RPLN in NPC

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To evaluate the safety and efficacy of a novel minimally invasive sampling technique -- fine needle aspiration (FNA) guided by endoscopic ultrasound (EUS), which aims to sample tissues from retropharyngeal lymph nodes (RPLN) for the diagnosis of patients with suspected recurrent nasopharyngeal carcinoma (NPC).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun yat-sen University Cancer Center

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. had undifferentiated, non-keratinizing carcinoma at the initial diagnosis (WHO, 1991 criteria) and no evidence of distant metastasis obtained before radiotherapy;
  2. received regular chemotherapy with cytotoxic agents such as cisplatin, carboplatin, 5-fluorouracil, paclitaxel, etc, and coordinated with radiotherapy with standard doses (approximate 50-70 Gy) in nasopharynx and neck respectively. Within 3 months after radiotherapy, no local and distant lesions were found;
  3. during regular follow-up , the enlarged RPLN was detected by MRI more than 6 months later since radiotherapy accomplished;
  4. didn't receive chemotherapy radiotherapy, immunotherapy or salvage surgery from completion of radiotherapy to suspicious recurrent lesion in RPLN detected;
  5. no recurrent lesion in nasopharynx was found by white light endoscopy as well as cancer cell negative in pathology by bite biopsy;
  6. single lesion in RPLN, and no other recurrent or metastatic lesion was found in local region or distant organ.
  7. the minimum axial diameter of RPLN was more than 5mm.

Exclusion Criteria:

  • (1) patients with nasal stenosis; (2) patients with coagulation dysfunction; (3) patients with distant metastasis

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EUS-FNA for RPLN in NPC patients
Fine needle aspiration guided by EUS in retropharyngeal lymph node in suspicious recurrent naspharyngeal carcinoma.
Procedure: EUS-FNA for RPLN in NPC patients
An EUS probe was introduced to nasopharynx and the retropharyngeal space (RPS) were scanned. The suspicious recurrent RPLN, which was characterized as (1) roughly round and homogeneously hypo-echoic lesion in RPS; (2) located anterior to the carotid sheath which contained the internal carotid artery (ICA) and the internal jugular vein (IJV). Subsequently, guiding by EUS, a dedicated 22G needle was used to puncture into the enlarged RPLN, then the aspiration was conducted The entire EUS-FNA procedure was repeated at least three times till the satisfied strip tissue was obtained. The obtained tissue samples were sent for pathologic detection and the supernatant fluid was for thinprep cytologic test (TCT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: Up to 24 weeks
Number of participants with cancer positive and negative
Up to 24 weeks

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Jian-jun Li, MD & Ph.D, Sun Yat-sen 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

January 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (ESTIMATE)

December 30, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 2, 2017

Last Update Submitted That Met QC Criteria

December 29, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUS-FNA for RPLN(2016)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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