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

Not Applicable

• Conditions: Cranial Sutures; Closure
• Interventions: Procedure: Dural closure

• Registration Number: NCT03910374
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-05
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-PRF	Dural closure	In this arm, dural closure will be performed with the autologous L-PRF
Classical Treatment	Dural closure	In this arm, dural closure will be performed with the classical fibrine sealants.

Primary Outcome Measures

Name	Time	Method
Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel).	4 years	Cost-effectiveness evaluation: compare the costs and the effectiveness of L-PRF versus commercial fibrin sealants.
To compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority	4 years	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.

Secondary Outcome Measures

Name	Time	Method
To identify potential risk for closure-failures based on the size of the lesion	4 years	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.
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the skull base questionnaire	4 years	Rhinological symptoms as well as quality of life before and after surgery will be assesed using the skull base questionnaire.
To evaluate if the pathology is a potential risk factor for closure-failures	4 years	The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the pathology will be evaluated.
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on a visual analogue scale	4 years	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".
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the SNOT-22	4 years	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".
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the EQ-5D	4 years	Rhinological symptoms as well as quality of life before and after surgery will be assesed using the EQ-5D
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	4 years	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.
To evaluate if the age of the patient is a potential risk factor for closure-failures	4 years	The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the age of the patients will be measured.

Trial Locations

Locations (3)

AZ Sint-Jan; 🇧🇪 Brugge, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Fundació Clínic Per A La Recerca Biomèdica; 🇪🇸 Barcelona, Spain