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

NCT07216157 | Recruiting FDA Device

• 1 other identifier: NIO-NS2025
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

CerebroSpinal Fluid (CSF) Leak

Keywords

csf; pituitary adenoma; csf leak; sealant

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative cerebrospinal fluid (CSF) leak within 90 days

  Postoperative CSF leak will be assessed clinically and endoscopically at multiple time points (Day 2, Day 30, Day 90). A leak will be defined as visible or symptomatic leakage of cerebrospinal fluid from the nasal cavity, confirmed by clinical exam and/or imaging when necessary. Assessment will be blinded and recorded using standardized diagnostic criteria.

  90 days

Study Arms (3)

No Sealant - Standard Multilayer Closure

EXPERIMENTAL

Patients in this arm will receive standard multilayer closure without the use of any sealant. Closure will involve mucosal flap repositioning and hemostatic agents (e.g., Surgicel®, TachoSil®), in accordance with standard endoscopic skull base reconstruction techniques.

Procedure: Standard multilayer closure without sealant

Fibrin Glue - Tisseel® Application

EXPERIMENTAL

Patients will undergo standard multilayer closure followed by application of fibrin sealant (Tisseel®). This arm evaluates the effect of biologic tissue glue in preventing postoperative CSF leaks and promoting wound healing following endonasal skull base surgery.

Device: Fibrin sealant application

Synthetic Sealant - Adherus® Application

EXPERIMENTAL

This arm involves standard multilayer closure followed by the application of a two-component synthetic polyethylene glycol-based sealant (Adherus®). The objective is to evaluate the synthetic agent's efficacy and cost-effectiveness in reducing postoperative CSF leaks.

Device: Synthetic polyethylene glycol-based sealant

Interventions

Standard multilayer closure without sealant PROCEDURE

Patients will undergo standard skull base reconstruction using mucosal flap repositioning and absorbable hemostatics (e.g., Surgicel®, TachoSil®), without application of any fibrin or synthetic sealant. This serves as the control group for comparison with sealant-assisted closures.

Also known as: No-sealant technique, Control arm

No Sealant - Standard Multilayer Closure

Fibrin sealant application DEVICE

Following standard multilayer closure, patients in this group will receive topical application of a fibrin-based biological sealant (Tisseel®). The intervention aims to assess its effectiveness in preventing postoperative cerebrospinal fluid (CSF) leak and promoting mucosal healing after endoscopic endonasal skull base surgery.

Also known as: Tisseel®, Fibrin glue, Human fibrinogen/thrombin sealant

Fibrin Glue - Tisseel® Application

Synthetic polyethylene glycol-based sealant DEVICE

After standard multilayer closure, a synthetic two-component sealant (Adherus®, composed of polyethylene glycol and polyethylenimine) will be applied to reinforce the reconstruction site. This group is used to evaluate the efficacy and safety of synthetic sealant in preventing CSF leaks and supporting wound healing.

Also known as: Adherus®, PEI/PEG sealant, Synthetic dural sealant

Synthetic Sealant - Adherus® Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

Maria Sklodowska-Curie Institute - Oncology Center

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms; Cerebrospinal Fluid Otorrhea

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Cerebrospinal Fluid Leak; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Central Study Contacts

Wojciech Czyzewski, MD PhD, MD PhD

CONTACT

+48788599550; wojciech.w.czyzewski@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wojciech Czyżewski MD, PhD, Neurosurgery Specialist, Principal Investigator

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 14, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: De-identified individual participant data (IPD) and supporting documentation will be available beginning 6 months after publication of the primary results and will remain accessible for up to 36 months.
• Access Criteria: Access will be granted to qualified researchers affiliated with academic or non-commercial institutions who submit a methodologically sound research proposal. Access will include de-identified IPD and supporting documents (protocol, SAP, ICF, CSR, analytic code). Requests should be sent to the corresponding author. Data will be shared via secure institutional data-sharing platforms upon approval of the proposal and execution of a data use agreement.

Locations

PL (1)