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Completed

NCT Number: NCT03910374

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.

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Key information

Conditions

Cranial Sutures; Closure

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Sint-Jan, Bruges, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dural closure

Procedure

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

Primary outcomes

  1. To compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority

    Time frame: 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.

  2. Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel).

    Time frame: 4 years

    Cost-effectiveness evaluation: compare the costs and the effectiveness of L-PRF versus commercial fibrin sealants.

Secondary outcomes

  1. To identify potential risk for closure-failures based on the size of the lesion

    Time frame: 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.

  2. To evaluate if the pathology is a potential risk factor for closure-failures

    Time frame: 4 years

    The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the pathology will be evaluated.

  3. To evaluate if the age of the patient is a potential risk factor for closure-failures

    Time frame: 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.

  4. Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on a visual analogue scale

    Time frame: 4 years

    Rhinological symptoms as well as quality of life before and after surgery will be assessed 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".

  5. Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the SNOT-22

    Time frame: 4 years

    Rhinological symptoms as well as quality of life before and after surgery will be assessed using a SNOT-22. The symptoms will be scored between 0 and 5 where 0 equals "no symptoms" and 5 equals "very severe symptoms".

  6. Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the skull base questionnaire

    Time frame: 4 years

    Rhinological symptoms as well as quality of life before and after surgery will be assessed using the skull base questionnaire.

  7. Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the EQ-5D

    Time frame: 4 years

    Rhinological symptoms as well as quality of life before and after surgery will be assessed using the EQ-5D

  8. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2019
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.