EUS-FNA for Retropharyngeal Lymph Node (RPLN) in Recurrent Nasopharyngeal Carcinoma (NPC) Patients
Primary Purpose
Nasopharyngeal Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
EUS-FNA for RPLN in NPC patients
Sponsored by
About this trial
This is an interventional diagnostic trial for Nasopharyngeal Carcinoma focused on measuring FNA,EUS,retropharyngeal lymph node (RPLN),NPC
Eligibility Criteria
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
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EUS-FNA for RPLN in NPC patients
Arm Description
Fine needle aspiration guided by EUS in retropharyngeal lymph node in suspicious recurrent naspharyngeal carcinoma.
Outcomes
Primary Outcome Measures
Accuracy
Number of participants with cancer positive and negative
Secondary Outcome Measures
Full Information
NCT ID
NCT03006588
First Posted
December 27, 2016
Last Updated
December 29, 2016
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03006588
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
FNA,EUS,retropharyngeal lymph node (RPLN),NPC
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EUS-FNA for RPLN in NPC patients
Arm Type
Experimental
Arm Description
Fine needle aspiration guided by EUS in retropharyngeal lymph node in suspicious recurrent naspharyngeal carcinoma.
Intervention Type
Procedure
Intervention Name(s)
EUS-FNA for RPLN in NPC patients
Intervention Description
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).
Primary Outcome Measure Information:
Title
Accuracy
Description
Number of participants with cancer positive and negative
Time Frame
Up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian-jun Li, MD & Ph.D
Phone
+862087342822
Email
lijj@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xin-xi Zhou, MD
Phone
+862087343135
Email
zhouxx@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian-jun Li, MD & Ph.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin-xi Zhou, MD
Phone
+862087343135
Email
zhouxx@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Jian-jun Li, MD & PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EUS-FNA for Retropharyngeal Lymph Node (RPLN) in Recurrent Nasopharyngeal Carcinoma (NPC) Patients
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