Clinical trial · Interventional
Benefit of Enhanced Contact Endoscopy in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions
Determination of Diagnostic Benefit of Enhanced Contact Endoscopy (ECE) in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions
NCT04777474CI-TRIAL-00062557unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypopharyngeal Lesions | — | UNRESOLVED | — |
| Laryngeal Disease | — | UNRESOLVED | — |
| Laryngeal Lesions | — | UNRESOLVED | — |
| Proven Hypopharyngeal Cancer | — | UNRESOLVED | — |
| Proven Laryngeal Cancer | — | UNRESOLVED | — |
| Suspected Hypopharyngeal Cancer | — | UNRESOLVED | — |
| Suspected Laryngeal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced contact endoscopy | Diagnostic Test | — | UNRESOLVED |
| IMAGE1S imaging | Diagnostic Test | — | UNRESOLVED |
| Narrow band imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Enhanced contact endoscopy
- description
- The study subjects will undergo enhanced contact endoscopy
- interventionNames
- Diagnostic Test: Enhanced contact endoscopy
- Diagnostic Test: Narrow band imaging
- Diagnostic Test: IMAGE1S imaging
Primary outcomes (5)
- measure
- Accuracy of enhanced contact endoscopy
- timeFrame
- Procedure (During the examination under general anaesthesia)
- description
- The accuracy of enhanced contact endoscopy will be observed (size of lesions in mm when compared with the other standard techniques)
- measure
- Sensitivity of enhanced contact endoscopy
- timeFrame
- Procedure (During the examination under general anaesthesia)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDPuxeddu 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
- BACKGROUNDMehlum 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