Benefit of Enhanced Contact Endoscopy in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions

NCT04777474 | Unknown

• 1 other identifier: 23/RVO-FNOs/2020
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

The focus of the study is to verify the role of enhanced contact endoscopy in early identification of high-risk vascular patterns of precancerous and malignant mucosal changes in ear-nose-throat (ENT) patients, in comparison with other standard imaging techniques.

Conditions

Laryngeal Disease; Laryngeal Lesions; Hypopharyngeal Lesions; Suspected Laryngeal Cancer; Suspected Hypopharyngeal Cancer; Proven Laryngeal Cancer; Proven Hypopharyngeal Cancer

Keywords

laryngeal cancer; hypopharyngeal cancer; laryngeal disease; enhanced contact endoscopy; narrow band imaging; IMAGE1S method

Outcome Measures

Primary Outcomes (5)

• Accuracy of enhanced contact endoscopy

  The accuracy of enhanced contact endoscopy will be observed (size of lesions in mm when compared with the other standard techniques)

  Procedure (During the examination under general anaesthesia)

• Sensitivity of enhanced contact endoscopy

  The sensitivity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.

  Procedure (During the examination under general anaesthesia)

• Specificity of enhanced contact endoscopy

  The specificity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.

  Procedure (During the examination under general anaesthesia)

• Positive predictive value of enhanced contact endoscopy

  The positive predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.

  Procedure (During the examination under general anaesthesia)

• Negative predictive value of enhanced contact endoscopy

  The negative predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.

  Procedure (During the examination under general anaesthesia)

Study Arms (1)

Enhanced contact endoscopy

EXPERIMENTAL

The study subjects will undergo enhanced contact endoscopy

Diagnostic Test: Enhanced contact endoscopy; Diagnostic Test: Narrow band imaging; Diagnostic Test: IMAGE1S imaging

Interventions

Enhanced contact endoscopy DIAGNOSTIC_TEST

The study subjects will undergo enhanced contact endoscopy - studied imaging technique

Enhanced contact endoscopy

Narrow band imaging DIAGNOSTIC_TEST

The study subjects will undergo narrow band imaging - comparator procedure

Enhanced contact endoscopy

IMAGE1S imaging DIAGNOSTIC_TEST

The study subjects will undergo IMAGE1S imaging - comparator procedure

Enhanced contact endoscopy

Eligibility Criteria

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

You may qualify if:

• Age 18 and older
• patients scheduled for direct hypopharyngoscopy and laryngoscopy in general anaesthesia
• benign laryngeal and hypoharyngeal disease/laryngeal and hypopharyngeal lesions of uncertain biologic behaviour (leukoplakia, erythroplakia, keratosis)
• patients with suspicious macroscopical lesion found during ENT examination/patients with histologically confirmed metastasis of carcinoma in neck lymph node with unknown primary origin of the tumour
• patients with recurrence of malign tumour in hypopharynx or larynx
• patients after radiotherapy indicated for follow up examination under general anaesthesia
• patients with persistent non-specific problems (hoarseness, swallowing problems etc.) indicated to direct laryngohypopharyngoscopy due to diagnostic purposes

You may not qualify if:

• age - younger than 17 years
• refusal to join the study

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (2)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

University Hospital Hradec Králové

Hradec Králové, Czechia

RECRUITING

Related Publications (2)

• Puxeddu R, Sionis S, Gerosa C, Carta F. Enhanced contact endoscopy for the detection of neoangiogenesis in tumors of the larynx and hypopharynx. Laryngoscope. 2015 Jul;125(7):1600-6. doi: 10.1002/lary.25124. Epub 2015 Jan 13.

  PMID: 25582112 BACKGROUND

• Mehlum CS, Dossing H, Davaris N, Giers A, Grontved AM, Kjaergaard T, Moller S, Godballe C, Arens C. Interrater variation of vascular classifications used in enhanced laryngeal contact endoscopy. Eur Arch Otorhinolaryngol. 2020 Sep;277(9):2485-2492. doi: 10.1007/s00405-020-06000-z. Epub 2020 Apr 30.

  PMID: 32350646 BACKGROUND

MeSH Terms

Conditions

Laryngeal Diseases; Laryngeal Neoplasms; Hypopharyngeal Neoplasms

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Pharyngeal Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Peter Kántor, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is being used in the study
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be enrolled into one study group.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 2, 2021
• Study Start: May 15, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)