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

Cranial Sutures; Closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03910374
• Other study ID #: s61636
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Laura Van Gerven, prof
• Phone: 003216332342
• Email: laura.vangerven[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cranial Sutures; Closure

Intervention

Procedure:
• Dural closure
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

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan	Brugge
Belgium	UZ Leuven	Leuven
Spain	Fundació Clínic Per A La Recerca Biomèdica	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Countries where clinical trial is conducted

Belgium,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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