Clinical trial NCT02584790: NBI to Detect Post-RT Mucosal Residual NPC
Official title: Using Narrow-band Imaging (NBI) Technique to Detect Post-radiotherapy Mucosal Residual Nasopharyngeal Carcinoma (NPC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
Narrow band imaging
Lead sponsor: Pamela Youde Nethersole Eastern Hospital
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient
timeFrame: Post-radiotherapy 8th week
Secondary outcomes:
measure: Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group
timeFrame: Post-radiotherapy eight weeks
measure: The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern
timeFrame: Post-radiotherapy eight weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
Study officials:
affiliation: Pamela Youde Nethersole Eastern Hospital
name: Wong Kai Chuen, MBChB, MRCS
role: PRINCIPAL_INVESTIGATOR
References: