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

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

Study Overview

• Status: Recruiting
• Conditions: Cranial Sutures; Closure
• Intervention / Treatment: Procedure: Dural closure

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 Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Van Gerven, prof; Phone Number: 003216332342; Email: laura.vangerven@uzleuven.be
• Study Contact Backup: Name: Anais Van Hoylandt, MSc; Phone Number: 003216342012; Email: anais.vanhoylandt@uzleuven.be

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Recruiting
    • AZ Sint-Jan
    • Contact: Kato Speleman, MD; Phone Number: 050 45 22 80; Email: Kato.Speleman@azsintjan.be
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Laura Van Gerven, prof; Phone Number: 003216 332342; Email: laura.vangerven@uzleuven.be
    • Contact: Anais Van Hoylandt; Phone Number: 003216342012; Email: anais.vanhoylandt@uzleuven.be
• Spain
  • Barcelona, Spain, 08036
    • Not yet recruiting
    • Fundació Clínic Per A La Recerca Biomèdica
    • Contact: Cristobal Langdon, prof; Email: clangdon@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Classical Treatment; In this arm, dural closure will be performed with the classical fibrine sealants.	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
Active Comparator: L-PRF; In this arm, dural closure will be performed with the autologous L-PRF	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Laura Van Gerven, prof, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: L-PRF; fibrin sealants; endoscopic endonasal skull base reconstruction
• Other Study ID Numbers: s61636

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No