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

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Procedure: EUS-FNA for RPLN in NPC patients

• Registration Number: NCT03006588
• Lead Sponsor: Sun Yat-sen University

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).

Study Timeline

• Study Start: 2014-01
• Status Verified: 2016-12
• Study First Submitted: 2016-12-27
• Study First Submitted QC: 2016-12-28
• Last Update Submitted: 2016-12-29
• Study First Posted: 2016-12-30
• Last Update Posted: 2017-01-02
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS-FNA for RPLN in NPC patients	EUS-FNA for RPLN in NPC patients	Fine needle aspiration guided by EUS in retropharyngeal lymph node in suspicious recurrent naspharyngeal carcinoma.

Primary Outcome Measures

Name	Time	Method
Accuracy	Up to 24 weeks	Number of participants with cancer positive and negative

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China