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

Sun Yat-sen University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Procedure: EUS-FNA for RPLN in NPC patients

Study type: Interventional

Funder types: Other

Identifiers

NCT03006588

EUS-FNA for RPLN(2016)

Details and patient eligibility

About

EUS-FNA for RPLN in NPC

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

EUS-FNA for RPLN in NPC patients

Experimental group

Description:

Fine needle aspiration guided by EUS in retropharyngeal lymph node in suspicious recurrent naspharyngeal carcinoma.

Treatment:

Procedure: EUS-FNA for RPLN in NPC patients