- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07512466
Evaluation of Endoscopic Management of Sinonasal Tumors In Difficult Anatomical Locations
April 1, 2026 updated by: Aya abdelnasser hassani, Assiut University
Research outcome measures:
Primary (main):
To Evaluate the Gross Total Resection Rate Using Endoscopic Approach for Lesions Extended To Anatomically Challenging Areas
Secondary (subsidiary):
- Assess postoperative improvement in Quality of Life
- Quantify intraoperative blood loss and surgical duration
- Document the incidence of complications (CSF leak, nerve palsy, vascular injury)
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Sinonasal tumors are a heterogeneous group of neoplasms arising from the nasal cavity and paranasal sinuses, representing a rare subset of head and neck tumors.
Tumors arising from the sinonasal cavity can be subdivided into benign and malignant characters .Sinonasal malignancy are rare, representing <1% of all malignancies and <5% of head and neck cancers.Benign sinonasal tumors are more common than malignant lesions and include inverted papilloma, hemangioma, osteoma, juvenile nasopharyngeal angiofibroma, and various fibrous and glandular neoplasms.(1)The
sinonasal cavity includes the epithelial, mesenchymal, salivary gland, cartilaginous and osseous proponents, and as such, it may lead to various original malignancies including the squamous cell carcinoma (most common) and the others (adenocarcinoma, adenoid cystic carcinoma, sarcoma, olfactory neuroblastoma,).(2)
Surgical resection is often the first step of the therapeutic strategy in treatment of sinonasal tumors, possibly combined with adjuvant therapies .Tumors at pterygopalatine and infratemporal fossae,sphenoid and maxillary sinus poses challenges to surgeons for their deep location and intimate relationship with highly functional neurovascular and osteo-muscular structures .(3)Tumors in these challenging regions were managed via invasive open surgical resection ,these interventions are frequently morbid, resulting in profound neurological and functional sequelae that adversely impact the patient's clinical outcomes.(4)
Endoscopic endonasal surgery become a standard approach in the management of many benign and selected malignant sinonasal tumors .It is as a minimally invasive surgical alternative, facilitating access to difficult locations with preserving the osteo-ligamental and muscular structures with no visible scars, optimal cosmetic outcome, and consequently limited risk of permanent neurological or functional deficits.(5)
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
-Patients with sinonasal and nasopharyngeal tumors
Exclusion Criteria:
- Extensive lesions required open approach ex (intraconal extension need orbital exenteration).
- Absolute contraindications to general anaesthesia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: endoscopic resection of sinonasal tumors
|
mangment of endoscopic approch in sinonasal tumors excision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Endoscopic Management of Sinonasal Tumors In Difficult Anatomical Locations
Time Frame: 4 years
|
To Evaluate the Gross Total Resection Rate Using Endoscopic Approach for Lesions Extended To Anatomically Challenging Areas
|
4 years
|
|
percentage of complete resection post operative
Time Frame: 2 years
|
complete resection of tumer by endoscopic approch
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
April 1, 2028
Study Registration Dates
First Submitted
March 17, 2026
First Submitted That Met QC Criteria
April 1, 2026
First Posted (Actual)
April 6, 2026
Study Record Updates
Last Update Posted (Actual)
April 6, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EEA in sinonasal tumors
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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