NBI to Detect Post-RT Mucosal Residual NPC

Pamela Youde Nethersole Eastern Hospital

Status: Completed

Conditions: Nasopharyngeal Carcinoma

Treatments: Device: Laryngoscope with NBI system

Study type: Interventional

Funder types: Other

Identifiers

NCT02584790

NBI1782015

Details and patient eligibility

About

NBI has been proven to be a useful tool to detect early NPC, but they were few studies concerning the detection of post-radiotherapy mucosal residual NPC using NBI system

Full description

Background

NPC has a uniquely high prevalence in Southern China. According to the Hong Kong Cancer Registry in 2012, NPC was the sixth commonest cancer in men and thirteenth in women. It accounted for 2.9% of all new cancer cases. In 2012, there were 819 new cases of NPC.

NPC is highly radiosensitive. Radiotherapy and chemotherapy are the mainstay of treatment. Despite the chemo-irradiation, disease control failure still occurred in NPC patients presenting as persistent tumor. Early detection of those post-radiotherapy residual NPC is essential for early arrangement of salvage therapy. Detection methods include imaging, plasma Epstein-Barr virus DNA, endoscopy examinations and nasopharynx biopsy.

NBI system has been well proven as a tool to detect early digestive tract cancer and head and neck cancer. However, there were only few studies targeting the detection of post-radiotherapy mucosal residual of NPC using NBI system

Objective

1. To identify the vessel pattern of those confirmed NPC case using NBI system
2. To identify the endoscopy features of post-radiotherapy mucosal residual nasopharyngeal carcinoma using NBI system
3. To establish the positive predicted value, negative predicted value, sensitivity and specificity of using NBI system for detecting mucosal residual NPC

Method:

1. All newly biopsy confirmed NPC patient will be assessed, their nasopharynx endoscopic image will be captured using both WL + NBI system
2. At post-radiotherapy 8th weeks, endoscopic examination will be arranged for patient using both WL + NBI system, biopsy will also be taken to detect mucosal residual NPC

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all new NPC patient

Exclusion criteria

• History of radiotherapy to head and neck region
• Poor premorbid status/ non-communicable patients
• <18 years old
• Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Post radiotherapy 8 weeks NPC patient

Other group

Description:

All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system

Treatment:

Device: Laryngoscope with NBI system