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Magnifying NBI for Occult NPC

NCT04593186 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2023-09-07

No results posted yet for this study

Summary

Diagnosis of nasopharyngeal carcinoma (NPC) is currently made by trans-nasal endoscopy and biopsy. The small caliber endoscope provides only a limited view of the nasopharynx and may not be able to provide a thorough assessment of the nasopharynx. The investigators have developed a novel endoscopic approach to access the nasopharynx by using a trans-oral high definition endoscope with magnification and image enhancement function. In this cohort study, we aim to investigate the efficacy of diagnosing NPC by applying the novel technique in a high risk patient group with elevated plasma EBV DNA but with negative screening with conventional trans-nasal endoscopy.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

PROCEDURE

Trans-oral magnifying endoscopy with NBI

Endoscopic procedures would be performed by endoscopists with expertise on performing magnifying NBI endoscopy. Topical local anaesthetic will be applied to the oropharynx and nasopharynx. In addition, intravenous sedation by use of Midazolam and Fentanyl would be given. Endoscopes with magnification and NBI function would be used (GF-H290Z, Olympus Medical Corporations, Tokyo, Japan). A soft black hood would be attached to the tip of the endoscope for better focal length adjustment. Upon insertion through a mouthpiece, the scope will then be retroflexed into the nasopharynx and the lateral walls into the Fossa of Rosenmuller and the posterior nasopharyngeal wall will be systematically examined with white light and NBI. Target suspicious areas would be examined by use of magnification with the power up to 80X. Biopsy would be taken if suspicious lesion is identified during the procedure.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Hon Chi Yip, MBChB, FRCSEd · Chinese University of Hong Kong

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2023-10-31
Completion
2024-11-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04593186 on ClinicalTrials.gov