Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2015-11-30
2017-04-30
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Post radiotherapy 8 weeks NPC patient
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
Laryngoscope with NBI system
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
Interventions
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Laryngoscope with NBI system
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Poor premorbid status/ non-communicable patients
* \<18 years old
* Pregnancy
18 Years
ALL
No
Sponsors
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Pamela Youde Nethersole Eastern Hospital
OTHER
Responsible Party
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Dr. Wong Kai Chuen
Doctor
Principal Investigators
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Wong Kai Chuen, MBChB, MRCS
Role: PRINCIPAL_INVESTIGATOR
Pamela Youde Nethersole Eastern Hospital
Locations
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Pamela Youde Nethersole Eastern Hospital
Hong Kong, , Hong Kong
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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NBI1782015
Identifier Type: -
Identifier Source: org_study_id