Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction

Study Overview
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Brief Summary
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Prospective investigation of the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery (transsphenoidal) versus classical closure techniques.

Detailed Description
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The investigators want to demonstrate in a prospective, randomized trial including 220 patients undergoing endoscopic endonasal skull base surgery that the use of L-PRF is non-inferior to classical fibrin sealants. Approximately 220 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded multicenter study to evaluate the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair.

Official Title
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Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction

Conditions
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Cranial Sutures; Closure

Intervention / Treatment
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* Procedure: Dural closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with lesions of the sellar/parasellar region Age > 18 and < 70 years Written informed consent Willingness to adhere to visit schedules Exclusion Criteria: Age < 18 and > 70 years Any underlying rhinological condition like nasal polyps, which may interfere with the obtained results Any disorder which might compromise the ability of a patient to give truly informed consent for participation in this study Enrollment in other investigational drug trial(s)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Classical Treatment<br>In this arm, dural closure will be performed with the classical fibrine sealants. | Procedure: Dural closure<br>* Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair<br>|
| Active Comparator: L-PRF<br>In this arm, dural closure will be performed with the autologous L-PRF | Procedure: Dural closure<br>* Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority | The primary aim of this study is identifying the role of L-PRF in the endoscopic endonasal closure of skull base defects. More specific, we want to demonstrate in a prospective, randomized trial that the use of L-PRF is non-inferior to classical closure techniques regarding prevalence of CSF-leaks The number of patients with a CSF-leak will be compared between both treatment groups. | 4 years | 
| Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel). | Cost-effectiveness evaluation: compare the costs and the effectiveness of L-PRF versus commercial fibrin sealants. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify potential risk for closure-failures based on the size of the lesion | The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based size of lesion ( evaluated by Wilson-Hardy classification) will be measured. | 4 years | 
| To evaluate if the pathology is a potential risk factor for closure-failures | The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the pathology will be evaluated. | 4 years | 
| To evaluate if the age of the patient is a potential risk factor for closure-failures | The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the age of the patients will be measured. | 4 years | 
| Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on a visual analogue scale | Rhinological symptoms as well as quality of life before and after surgery will be assesed using a visual analogue scale. The symptoms will be scored on a horizontal line of 10 cm, where 0 cm equals no symptoms and 10 cm equals very severe symptoms. | 4 years | 
| Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the SNOT-22 | Rhinological symptoms as well as quality of life before and after surgery will be assesed using a SNOT-22. The symptoms will be scored between 0 and 5 where 0 equals no symptoms and 5 equals very severe symptoms. | 4 years | 
| Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the skull base questionnaire | Rhinological symptoms as well as quality of life before and after surgery will be assesed using the skull base questionnaire. | 4 years | 
| Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the EQ-5D | Rhinological symptoms as well as quality of life before and after surgery will be assesed using the EQ-5D | 4 years | 
| Evaluate the potential interference of the L-PRF membranes with post-operative imaging by comparing the tumor residue evaluation 3 months and 1 year after surgery | potential interference of the L-PRF membranes with post-operative imaging (MRI) will be evaluated. 3 months after surgery, when the L-PRF membrane is still visible, the MRI images will be evaluated to see if there is tumor residue present or not. After 1 year the presence of tumor residue will be reevaluated. The outcomes will be compared between both evaluation timepoints to asses if L-PRF has interference with the imaging. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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L-PRF, fibrin sealants, endoscopic endonasal skull base reconstruction