To Evaluate Transoral Flexible Endoscope With Narrow Band Imaging in Nasopharyngeal Cancer

NCT04419324 | Unknown

• 1 other identifier: 01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Nasopharyngeal carcinoma (NPC) is endemic in our region and is the 9th most common cancer in Hong Kong. Traditionally diagnosis has been through a nasoendoscopic examination of the nasopharynx with white light followed by a biopsy of suspicious lesions for a confirmatory diagnosis. However, given the geometry of the anatomy of the nasopharynx, with its inherent crevices and varying amounts of lymphoid tissues, lesions are not always easily identified leading to potential missed lesions. The non-specific aspect of white light also leads to excessive biopsies that are not without risk and of some discomfort to patients. Recent advances in liquid biopsies have also allowed for the detection of earlier and smaller lesions that are not always easily identified on nasoendoscopy but rather are seen on Magnetic Resonance Imaging (MRI)1 . An alternative imaging technique is the use of Narrow Band Imaging (NBI) to view the vasculature of the mucosa to identify suspicious lesions for pre-malignancy and malignancy that has been popularized in the gastrointestinal tract. In NPC, NBI with the flexible nasoendoscopes has been used in the diagnosis of NPC with varying success2-5 . Our own group's research has found that in NPC NBI has limitations arising from a lack of consensus on vascular findings on NBI that constitute malignancy, lack of magnification and long focal length of current nasoendoscopes5-8 . Flexible endoscopy using conventional esophago-gastroscopy endoscope (OGD) with NBI and magnification power up to 80x overcome the limitations of current nasoendoscopes, however their size precludes the passing of these endoscopes through the nasal cavity. Here in this pilot study we will seek to use an OGD with NBI passed transorally and retroflexed into the nasopharynx to view the nasopharynx with increased magnification and clarity to evaluate the feasibility of this study in the diagnosis of nasopharyngeal carcinoma. Study questions:

1. 1.Is it feasible to use an OGD with magnifying NBI for the diagnosis of NPC?
2. 2.Are there features detected on NBI OGD that are diagnostic of NPC?
3. 3.Do histological features correspond with NBI findings?

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• The vasculature of the nasopharyngeal region

  The vasculature of the nasopharyngeal region which capture by the transoral flexible endoscope with magnifying narrow band imaging

  during enrollment period

Secondary Outcomes (1)

• Histological features of nasopharyngeal lesion

  during enrollment period

Study Arms (1)

esophago-gastroscopy endoscopy with narrow band imaging

OTHER

a transoral flexible endoscope with magnifying narrow band imaging in nasopharyngeal examination

Device: transoral flexible endoscope with magnifying narrow band imaging

Interventions

transoral flexible endoscope with magnifying narrow band imaging DEVICE

To use an esophago-gastroscopy endoscope (OGD) with Narrow Band Imaging (NBI) passed transorally and retroflexed into the nasopharynx to view the nasopharynx with increased magnification and clarity for the diagnosis of nasopharyngeal carcinoma.

esophago-gastroscopy endoscopy with narrow band imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No previous radiotherapy to the head and neck region
• Years and older
• Able to provide informed consent
• No cognitive impairment
• \) Patients undergoing an OGD for lesions not involving disease of the head and neck region

You may not qualify if:

• On anticoagulation including Plavix, warfarin and NOAC's
• Current mucosal lesions of the head and neck region
• History of malignancy
• Concomitant malignant disease
• Trismus preventing an OGD

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jason Chan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cherrie NG

CONTACT

+852 35051409; cherrieng@ent.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Chan, Jason Ying Kuen

Model Details: This is a case-control pilot study

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 5, 2020
• Study Start: June 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share