NCT07216157 NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery
| NCT ID | NCT07216157 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology |
| Condition | CerebroSpinal Fluid (CSF) Leak |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 225 participants in total. It began in 2025-08-15 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07216157 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CerebroSpinal Fluid (CSF) Leak. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07216157 currently recruiting?
Yes, NCT07216157 is actively recruiting participants. Contact the research team at wojciech.w.czyzewski@gmail.com for enrollment information.
Where is the NCT07216157 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT07216157 clinical trial?
NCT07216157 is sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. The trial plans to enroll 225 participants.