EUS-FNA for Retropharyngeal Lymph Node (RPLN) in Recurrent Nasopharyngeal Carcinoma (NPC) Patients
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ClinicalTrials.gov Identifier: NCT03006588 |
Recruitment Status : Unknown
Verified December 2016 by Jian-jun Li, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : December 30, 2016
Last Update Posted : January 2, 2017
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Condition or disease | Intervention/treatment | Phase |
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Nasopharyngeal Carcinoma | Procedure: EUS-FNA for RPLN in NPC patients | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Fine Needle Aspiration of Retropharyngeal Lymph Node Guided by Endoscopic Ultrasound for the Diagnosis of Patients With Suspected Recurrent Nasopharyngeal Carcinoma |
Study Start Date : | January 2014 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
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Experimental: EUS-FNA for RPLN in NPC patients
Fine needle aspiration guided by EUS in retropharyngeal lymph node in suspicious recurrent naspharyngeal carcinoma.
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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). |
- Accuracy [ Time Frame: Up to 24 weeks ]Number of participants with cancer positive and negative

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- had undifferentiated, non-keratinizing carcinoma at the initial diagnosis (WHO, 1991 criteria) and no evidence of distant metastasis obtained before radiotherapy;
- 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;
- during regular follow-up , the enlarged RPLN was detected by MRI more than 6 months later since radiotherapy accomplished;
- didn't receive chemotherapy radiotherapy, immunotherapy or salvage surgery from completion of radiotherapy to suspicious recurrent lesion in RPLN detected;
- no recurrent lesion in nasopharynx was found by white light endoscopy as well as cancer cell negative in pathology by bite biopsy;
- single lesion in RPLN, and no other recurrent or metastatic lesion was found in local region or distant organ.
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006588
Contact: Jian-jun Li, MD & Ph.D | +862087342822 | lijj@sysucc.org.cn | |
Contact: Xin-xi Zhou, MD | +862087343135 | zhouxx@sysucc.org.cn |
China, Guangdong | |
Sun Yat-sen University Cancer Center | Recruiting |
Guangzhou, Guangdong, China, 510060 | |
Contact: Xin-xi Zhou, MD +862087343135 zhouxx@sysucc.org.cn | |
Principal Investigator: Jian-jun Li, MD & PhD |
Principal Investigator: | Jian-jun Li, MD & Ph.D | Sun Yat-sen University |
Responsible Party: | Jian-jun Li, Associate Professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT03006588 |
Other Study ID Numbers: |
EUS-FNA for RPLN(2016) |
First Posted: | December 30, 2016 Key Record Dates |
Last Update Posted: | January 2, 2017 |
Last Verified: | December 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
FNA,EUS,retropharyngeal lymph node (RPLN),NPC |
Carcinoma Nasopharyngeal Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Nasopharyngeal Neoplasms Pharyngeal Neoplasms |
Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |