UnknownNot Applicable

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

Czechia150 participantsStarted 2021-05-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * age - younger than 17 years * refusal to join the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Accuracy of enhanced contact endoscopy

Timeframe: Procedure (During the examination under general anaesthesia)

Sensitivity of enhanced contact endoscopy

Timeframe: Procedure (During the examination under general anaesthesia)

Specificity of enhanced contact endoscopy

Timeframe: Procedure (During the examination under general anaesthesia)

Positive predictive value of enhanced contact endoscopy

Timeframe: Procedure (During the examination under general anaesthesia)

Negative predictive value of enhanced contact endoscopy

Timeframe: Procedure (During the examination under general anaesthesia)

Trial details

NCT IDNCT04777474

SponsorUniversity Hospital Ostrava

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Jiří Hynčica

0042059737 jiri.hyncica@fno.cz

View on ClinicalTrials.gov More Laryngeal Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Accuracy of enhanced contact endoscopy

Timeframe: Procedure (During the examination under general anaesthesia)

Sensitivity of enhanced contact endoscopy

Timeframe: Procedure (During the examination under general anaesthesia)

Specificity of enhanced contact endoscopy

Timeframe: Procedure (During the examination under general anaesthesia)

Positive predictive value of enhanced contact endoscopy

Timeframe: Procedure (During the examination under general anaesthesia)

Negative predictive value of enhanced contact endoscopy

Timeframe: Procedure (During the examination under general anaesthesia)