Magnifying NBI for Occult NPC

NCT04593186 | Unknown

• 1 other identifier: CRE-2020.426
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

nasopharyngeal carcinoma, Narrow band Imaging, Magnifying endoscopy

Outcome Measures

Primary Outcomes (1)

• Rate of Newly diagnosed Nasopharyngeal cancer

  Newly diagnosed nasopharyngeal cancer with the novel endoscopic approach

  1 month

Secondary Outcomes (7)

• Rate of Adverse event - overall

  7 days

• Rate of adverse event - haemorrhage

  7 days

• Rate of adverse event - perforation

  7 days

• Rate of adverse event - infection

  7 days

• Rate of adverse event - aspiration pneumonia

  7 days

Study Arms (1)

Trans-oral magnifying endoscopy with NBI

EXPERIMENTAL

Transoral magnifying endoscopy with High Definition Upper Endoscope with Narrow Band Imaging enhancement (Olympus GIF-H290Z)

Procedure: Trans-oral magnifying endoscopy with NBI

Interventions

Trans-oral magnifying endoscopy with NBI PROCEDURE

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.

Trans-oral magnifying endoscopy with NBI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, age ≥ 18 years old
• Positive result on plasma EBV-DNA analysis
• No cancer identified on conventional investigations including nasoendoscopy and MRI

You may not qualify if:

• History of nasopharyngeal, oropharyngeal cancer
• Patients on anticoagulation (Including warfarin and other direct oral anti-coagulants)
• Bleeding tendency (International Normalized Ratio (INR) \> 1.5 or Platelet \< 50 x109/L)
• Trismus, unable to pass oral endoscope
• Allergic to local anaesthetic agents (Lignocaine)
• Failure of vital organ (heart, lungs, liver, or kidneys) function
• Other conditions deemed unsuitable for endoscopy
• Refusal to participate, or inability to sign consent for study

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Narrow Band Imaging

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

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Hon Chi Yip, MBChB, FRCSEd

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hon Chi Yip, MBChB, FRCSEd

CONTACT

35052956; hcyip@surgery.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: Associate consultant

Model Details: Trans-oral magnifying endoscopy with Narrow Band Imaging assessment of nasopharynx

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: April 15, 2021
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)