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 Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Accuracy
Condition
Nasopharyngeal Carcinoma
Intervention
EUS-FNA for RPLN in NPC patients
Study Arms / Comparison Groups
EUS-FNA for RPLN in NPC patients
Description: Fine needle aspiration guided by EUS in retropharyngeal lymph node in suspicious recurrent naspharyngeal carcinoma.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
January 2014
Completion Date
December 2018
Primary Completion Date
December 2018
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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Jian-jun Li, MD & Ph.D, +862087342822, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03006588
Organization ID
EUS-FNA for RPLN(2016)
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
Jian-jun Li, MD & Ph.D, Principal Investigator, Sun Yat-sen University
Verification Date
December 2016