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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03006588
Enrollment
100
Registered
2016-12-30
Start date
2014-01-31
Completion date
2018-12-31
Last updated
2017-01-02

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

Conditions

Nasopharyngeal Carcinoma

Keywords

FNA,EUS,retropharyngeal lymph node (RPLN),NPC

Brief summary

EUS-FNA for RPLN in NPC

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).

Interventions

PROCEDUREEUS-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).

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AccuracyUp to 24 weeksNumber of participants with cancer positive and negative

Countries

China

Contacts

Primary ContactJian-jun Li, MD & Ph.D
lijj@sysucc.org.cn+862087342822
Backup ContactXin-xi Zhou, MD
zhouxx@sysucc.org.cn+862087343135

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026