Sealant versus no sealant to prevent CSF leaks after endoscopic endonasal skull base surgery
The NoSeal Trial - Nasal Outcome Study Evaluating Artificial Leak-Sealing: A Prospective, Randomized, Controlled, Single-Blinded, Single-Center Clinical Trial Comparing Fibrin Glue (Tisseel®) and a Two-Component Synthetic Polymer Sealant (PEI/PEG, Adherus®) Versus No Sealant for the Prevention of Cerebrospinal Fluid Leak and Promotion of Wound Healing Following Endonasal Skull Base Surgery, Designed in Accordance With the SPIRIT 2025 Guidelines
We will try fibrin or synthetic sealants versus no sealant to see if they prevent postoperative CSF leaks in adults having endoscopic endonasal skull base surgery who are judged to be at low risk for leaks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology Academic / other |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT07216157 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled, single-center trial at the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland. Adults undergoing standard endoscopic endonasal skull base reconstruction who are perioperatively judged to be at low risk for CSF leak will be randomized preoperatively into one of three arms: multilayer closure without sealant, fibrin sealant application, or a synthetic polyethylene glycol–based sealant. Outcomes will include postoperative CSF leak rates, complications, and resource use with follow-up to capture early leaks and related interventions. The goal is to determine whether routine sealant use provides measurable clinical or economic benefit over no sealant in this low-risk population.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for endoscopic endonasal surgery with standard skull base reconstruction who are hemodynamically stable and perioperatively judged to have a low risk of postoperative CSF leak are ideal candidates.
Not a fit: Patients undergoing revision or extended endoscopic approaches, those with preoperative hydrocephalus, prior sellar/parasellar radiotherapy, uncontrolled diabetes, active sinus infection, known sealant allergy, or other factors requiring complex reconstruction are unlikely to benefit from this low-risk-focused comparison.
Why it matters
Potential benefit: If successful, the approach could spare low-risk patients unnecessary sealant use, lower costs and procedure complexity, and avoid sealant-related complications without increasing CSF leak rates.
How similar studies have performed: Recent high-quality observational studies and systematic reviews have questioned routine sealant benefit and cost-effectiveness, and this is the first randomized trial directly comparing fibrin and synthetic sealants versus no sealant in low-risk endonasal cases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Scheduled for endoscopic endonasal surgery involving standard skull base reconstruction * Informed written consent obtained prior to enrollment * Hemodynamic and electrolyte stability before surgery * Procedure expected to be completed without use of high-flow intraoperative CSF diversion techniques Exclusion Criteria: * Revision surgery or extended endoscopic approaches requiring complex reconstruction (e.g., clival or cribriform defects) * Tumors requiring complex sella reconstruction from the start * Preoperative hydrocephalus * Known allergy to fibrin-based or synthetic sealant components * Active sinus infection or systemic inflammatory disease * Prior radiotherapy to the sellar or parasellar region * Uncontrolled diabetes mellitus (HbA1c \> 7.0%) * Participation in another interventional trial that may influence wound healing or CSF assessment * Radiologic signs of chronic intracranial hypertension or hypotension
Where this trial is running
Warsaw
- Maria Sklodowska-Curie Institute - Oncology Center — Warsaw, Poland (Recruiting)
Study contacts
- Study coordinator: Wojciech Czyzewski, MD PhD, MD PhD
- Email: wojciech.w.czyzewski@gmail.com
- Phone: +48788599550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.