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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03006588
• Other study ID #: EUS-FNA for RPLN(2016)
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 27, 2016
• Last updated: December 29, 2016
• Start date: January 2014
• Est. completion date: December 2018

Study information

• Verified date: December 2016
• Source: Sun Yat-sen University
• Contact: Jian-jun Li, MD & Ph.D
• Phone: +862087342822
• Email: lijj[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

EUS-FNA for RPLN in NPC

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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).

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	Number of participants with cancer positive and negative	Up to 24 weeks	Yes