Clinical trial NCT03910374: Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction
Official title: Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cranial Sutures; Closure
Keywords: L-PRF
fibrin sealants
endoscopic endonasal skull base reconstruction
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: To compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority
timeFrame: 4 years
measure: Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel).
timeFrame: 4 years
Secondary outcomes:
measure: To identify potential risk for closure-failures based on the size of the lesion
timeFrame: 4 years
measure: To evaluate if the pathology is a potential risk factor for closure-failures
timeFrame: 4 years
measure: To evaluate if the age of the patient is a potential risk factor for closure-failures
timeFrame: 4 years
measure: Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on a visual analogue scale
timeFrame: 4 years
measure: Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the SNOT-22
timeFrame: 4 years
measure: Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the skull base questionnaire
timeFrame: 4 years
measure: Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the EQ-5D
timeFrame: 4 years
measure: 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
timeFrame: 4 years
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Leuven
country: Belgium
facility: UZ Leuven
city: Barcelona
country: Spain
facility: Fundació Clínic Per A La Recerca Biomèdica
Study officials:
affiliation: UZ Leuven
name: Laura Van Gerven, prof
role: PRINCIPAL_INVESTIGATOR
References: