NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery

Recruiting now · Not applicable

Conditions studied: CerebroSpinal Fluid (CSF) Leak

In brief

Postoperative cerebrospinal fluid (CSF) leak is a significant complication of endoscopic endonasal approaches (EEA) to the skull base. The use of tissue sealants such as fibrin glue (Tisseel) or synthetic agents (PEI/PEG) is widespread in surgical practice, however, recent high-quality evidence challenges their clinical benefit and cost-effectiveness. This study aims to investigate whether the routine use of sealants in patient with peri-operatively assessed low CSF leak risk, significantly improves outcomes over no sealant use, to guide more cost- effective, evidence-based closure strategies. To the best of our knowledge, the present study is the first randomized clinical trial to evaluate the necessity and comparative effectiveness of fibrin and synthetic sealants versus no sealant in preventing postoperative CSF leaks following endoscopic endonasal surgery in low-post operative CSF leak risk patients.

Key facts

Study ID

NCT07216157

Run by

Maria Sklodowska-Curie National Research Institute of Oncology

People needed

225

Starts

2025-08-15

Expected to finish

2027-03-15

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Maria Sklodowska-Curie Institute - Oncology Center — Warsaw, Poland (enrolling)

Full record on ClinicalTrials.gov

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