Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers

NCT02035735 | Completed

• 1 other identifier: 13 203 02
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.

Conditions

Squamous Cell Carcinoma of Oropharynx; Squamous Cell Carcinoma of Hypopharynx; Squamous Cell Carcinoma of Larynx

Keywords

NBI,; squamous cell carcinoma,; pharynx, larynx, surgical margins.

Outcome Measures

Primary Outcomes (1)

• Number of patients for whom superficial extension of the tumors has been increased by NBI.

  4 minutes

Secondary Outcomes (4)

• Number of tumors upstaged.

  4 minutes

• Contribution of the NBI in the diagnosis of other synchronous locations.

  4 minutes

• Contribution of the NBI in the diagnosis of pre-neoplastic lesions.

  4 minutes

• Contribution of the NBI in the evaluation of surgical margins.

  4 minutes

Study Arms (1)

Videoendoscopy with WL and NBI

EXPERIMENTAL

The day before the laryngoscopy under general anesthesia (LGA), two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light (WL) and the second one with NBI (NBI).

Procedure: WL and NBI

Interventions

WL and NBI PROCEDURE

For each patient with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx for whom a laryngoscopy under general anesthesia (LGA) is expected benefit the day before a transnasal endoscopy with white lamp (WL) and NBI by two different operators. Suspected mucosal abnormalities showed by one or the two technics are reported in a table wich describes the different areas of the pharynx and the larynx. During the LGA, several biopsies are performed and identified (WL and/or NBI).

Videoendoscopy with WL and NBI

Eligibility Criteria

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

You may qualify if:

• \- Patients who can benefit a laryngoscopic exam under general anesthesia

You may not qualify if:

• General anesthesia contra-indications
• Local anesthesia allergy
• Breast-feeding period or pregnancy

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University of Toulouse

Toulouse, 31059, France

Location

Related Publications (1)

• Chabrillac E, Espinasse G, Lepage B, Uro-Coste E, Dupret-Bories A, De Bonnecaze G, Vergez S. Contribution of narrow band imaging in delineation of laryngopharyngeal superficial cancer spread: a prospective study. Eur Arch Otorhinolaryngol. 2021 May;278(5):1491-1497. doi: 10.1007/s00405-020-06499-2. Epub 2021 Jan 5.

  PMID: 33398548 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell; Laryngeal Diseases; Margins of Excision

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sébastien VERGEZ, MD, PhD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 14, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)