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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

About this trial

This is an interventional diagnostic trial for Nasopharyngeal Carcinoma focused on measuring FNA,EUS,retropharyngeal lymph node (RPLN),NPC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

lijj@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xin-xi Zhou, MD

Phone

+862087343135

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

zhouxx@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Jian-jun Li, MD & PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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