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Do surgical glues really prevent brain fluid leaks? new trial aims to find out

NCT ID NCT07216157

Disease control Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of surgical sealants (fibrin glue and a synthetic polymer) against no sealant in preventing cerebrospinal fluid leaks after nose-based skull base surgery. About 225 adults with low leak risk will be randomly assigned to one of three groups. The goal is to see if sealants actually improve outcomes, helping surgeons make more evidence-based and cost-effective decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fibrin glue (Tisseel) and synthetic polymer sealant (Adherus)
What this could lead to
If successful, this could show that sealants are unnecessary for low-risk patients, saving costs and avoiding potential side effects.
What could go wrong
This is a single-center trial with 225 participants, so results may not apply broadly. The study focuses on low-risk patients, so findings may not extend to higher-risk cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cerebrospinal fluid leak Cerebrospinal Fluid Otorrhea Pituitary Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebrospinal fluid (CSF) leak

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Maria Sklodowska-Curie Institute - Oncology Center

    RECRUITING

    Warsaw, Poland

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