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

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ClinicalTrials.gov Identifier: NCT03006588
Recruitment Status : Unknown
Verified December 2016 by Jian-jun Li, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : December 30, 2016
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
Jian-jun Li, Sun Yat-sen University

Study Description
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Brief Summary:
EUS-FNA for RPLN in NPC

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Procedure: EUS-FNA for RPLN in NPC patients Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fine Needle Aspiration of Retropharyngeal Lymph Node Guided by Endoscopic Ultrasound for the Diagnosis of Patients With Suspected Recurrent Nasopharyngeal Carcinoma
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy [ Time Frame: Up to 24 weeks ]
    Number of participants with cancer positive and negative


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03006588


Contacts
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Contact: Jian-jun Li, MD & Ph.D +862087342822 lijj@sysucc.org.cn
Contact: Xin-xi Zhou, MD +862087343135 zhouxx@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Xin-xi Zhou, MD    +862087343135    zhouxx@sysucc.org.cn   
Principal Investigator: Jian-jun Li, MD & PhD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Jian-jun Li, MD & Ph.D Sun Yat-sen University
More Information
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Responsible Party: Jian-jun Li, Associate Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03006588    
Other Study ID Numbers: EUS-FNA for RPLN(2016)
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jian-jun Li, Sun Yat-sen University:
FNA,EUS,retropharyngeal lymph node (RPLN),NPC
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
 Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases