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

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

Tracking Information

• First Submitted Date: December 27, 2016
• First Posted Date: December 30, 2016
• Last Update Posted Date: January 2, 2017
• Study Start Date: January 2014
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 29, 2016)

Accuracy [ Time Frame: Up to 24 weeks ]

Number of participants with cancer positive and negative

• Original Primary Outcome Measures (submitted: December 28, 2016): Accuracy [ Time Frame: Up to 24 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: EUS-FNA for Retropharyngeal Lymph Node (RPLN) in Recurrent Nasopharyngeal Carcinoma (NPC) Patients
• Official Title: Fine Needle Aspiration of Retropharyngeal Lymph Node Guided by Endoscopic Ultrasound for the Diagnosis of Patients With Suspected Recurrent Nasopharyngeal Carcinoma
• 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 Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Nasopharyngeal Carcinoma

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).

Study Arms

Experimental: EUS-FNA for RPLN in NPC patients

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

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 28, 2016): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2018
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03006588
• Other Study ID Numbers: EUS-FNA for RPLN(2016)
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Jian-jun Li, Sun Yat-sen University
• Study Sponsor: Sun Yat-sen University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jian-jun Li, MD & Ph.D; Sun Yat-sen University

• PRS Account: Sun Yat-sen University
• Verification Date: December 2016