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Brain Tumor AdultCSF-IMRNCT07411690

Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors

An observational study of Brain Tumor Adult and Brain Tumor Benign, run by Medical University of Warsaw at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Cerebrospinal fluid is a clear fluid that surrounds and protects the brain. During surgery for brain tumors, neurosurgeons often need to open the covering of the brain (the dura) to reach the tumor. At the end of the operation, this covering is carefully closed again. Read more about this study

Who is it for?
Ages 18 years and older
How many people
200 participants
Where
1 sitePoland
Study dates
3 Feb 2026to Apr 2028
How long will I take part?
6 Weeks
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients qualified for supratentorial craniotomy for intracranial tumor.

Who may be able to join

  • Male or female at least 18 years old
  • Qualified for a craniotomy due to supratentorial intracranial tumor

Who cannot join

  • Revision surgery due to recurrent brain tumor
  • Emergency neurosurgical procedure

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michal Senger, M.D. contact

+48 791 760 040

michal.senger@wum.edu.pl

Poland1 site, 1 recruiting
  • Department of Neurosurgery of Medical Univeristy of Warsaw

    Warsaw, 02-097

    Michal Senger, M.D., +48 791 760 040, michal.senger@wum.edu.pl

    Recruiting

Other trials in Poland

About this study

Official title: Cerebrospinal Fluid Leak Incidence, Management and Risk Factor After Supratentorial Craniotomy for Intracranial Tumors: a Prospective Observational Study.

Cerebrospinal fluid is a clear fluid that surrounds and protects the brain. During surgery for brain tumors, neurosurgeons often need to open the covering of the brain (the dura) to reach the tumor. At the end of the operation, this covering is carefully closed again. In some cases, the closure might not be completely adequate leading to cerebrospinal fluid leak. This leakage may collect under the scalp or flow out through the surgical wound. When this happens, the surgical wound may not heal properly, and the risk of infection can increase. These complications can delay recovery and may postpone additional treatments, such as radiotherapy or chemotherapy, that are often needed after brain tumor surgery. Although cerebrospinal fluid leakage is less common after supratentorial craniotomy (surgery on the upper part of the brain) than after other types of brain surgery, it remains a challenging complication and has not been well studied in this group of patients. The aim of this study is to determine how often cerebrospinal fluid leakage occurs after supratentorial craniotomy for intracranial tumors, identify factors that increase the risk of leakage, and evaluate how these leaks are managed. Understanding these factors may help reduce the occurrence of cerebrospinal fluid leakage and improve postoperative recovery in the future.

Read the detailed description

Cerebrospinal fluid is a fluid that circulates within the subarachnoid space between the brain surface and the meningeal layers, providing mechanical protection and metabolic support to the central nervous system. During neurosurgical procedures for intracranial tumors, opening of the meningeal layers, including the dura mater, is routinely required to access deeper cerebral structures. At the conclusion of surgery, meticulous dural closure is performed to restore a watertight barrier. However, in certain cases, dural reconstruction may be insufficient, resulting in postoperative cerebrospinal fluid leakage.

Cerebrospinal fluid leakage may manifest as accumulation of fluid beneath the scalp tissues or as external drainage through the surgical wound margins. The presence of cerebrospinal fluid leakage compromises normal wound healing and increases the risk of postoperative complications, including superficial and deep surgical site infections. These complications may delay wound healing, prolong hospitalization, and affect the timing of postoperative adjuvant therapies such as radiotherapy or chemotherapy in patients with intracranial tumors. Although cerebrospinal fluid leakage is more commonly associated with infratentorial procedures, it remains a significant and challenging complication following supratentorial craniotomy. Despite its clinical relevance, cerebrospinal fluid leakage after supratentorial tumor surgery is relatively under investigated, and data regarding its incidence, risk factors, and optimal management strategies remain limited. This prospective observational study aims to evaluate the incidence of cerebrospinal fluid leakage following supratentorial craniotomy for intracranial tumors, identify patient and surgery related risk factors, and assess the effectiveness of various management and treatment modalities. All patients undergoing supratentorial craniotomy for intracranial tumor resection will be prospectively observed, and those who develop postoperative cerebrospinal fluid leakage will be identified and analyzed. Data collection will include tumor related anatomical characteristics, dural closure techniques, materials used for dural reconstruction, and therapeutic interventions employed for the management of cerebrospinal fluid leakage. Patients will be followed for a period of six weeks postoperatively, corresponding to the typical timeframe for initiation of adjuvant oncological treatment. The findings of this study aim to improve understanding of cerebrospinal fluid leakage in supratentorial craniotomies and may contribute to the development of strategies to reduce its incidence and associated complications in the future.

Keywords
intracranial tumor, cerebrospinal fluid leak, supratentorial craniotomy, glioma, meningioma
Medical subject headings
Brain Neoplasms, Glioblastoma, Glioma, Meningioma, Cerebrospinal Fluid Leak

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07411690
Study groupRoleWhat they receive
Patients qualified for a supratentorial craniotomy for intracranial tumorPatients who are qualified for a supratentorial craniotomy for intracranial tumor who need neither urgent neurosurgical treatment or secondary surgery due to tumor progression.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cerebrospinal fluid leakage occurrence.

    Any occurrence of cerebrospinal fluid leakage, both internal (fluid accumulating beneath the scalp) and external (fluid draining through the wound margins) will be considered as a primary outcome.

    Measured: From the enrollment till the end of observation period (6 weeks postoperatively)

Secondary outcomes (9)
  1. Surgical site infections incidence.

    Occurrence of any type of surgical site infections including superficial infections (skin reddening, serous or purulent discharge, wound tissues edema) and deep infections (epidural or subdural empyema, meningitis, brain abscess).

    Measured: From the enrollment till the end of observation period (6 weeks postoperatively).

  2. Unplanned outpatient clinic or emergency department visits due to cerebrospinal fluid leak.

    Incidence of additional, unplanned outpatient clinic or emergency department visits due to confirmed cases of cerebrospinal fluid leak - both internal and external.

    Measured: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.

  3. Hospitalization due to cerebrospinal fluid leak.

    Incidence of unplanned, additional hospitalizations due to cerebrospinal fluid leak.

    Measured: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.

  4. Treatment modalities of cerebrospinal fluid leak.

    Duration and efficacy of each cerebrospinal fluid leak treatment modality, such as: lumbar drainage, pharmacotherapy (acetazolamide therapy), compressive head dressing, secondary surgical intervention.

    Measured: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.

  5. Antibiotic therapy.

    Total duration and incidence of additional antibiotic therapy in cases of cerebrospinal fluid leak.

    Measured: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.

  6. Dura restoration techniques.

    Analysis of techniques utilized for restoration of dural integrity during primary surgical intervention, including: dura suturing, placement of artificial sealants.

    Measured: From the enrollment till the end of observation period (6 weeks postoperatively).

  7. Scalp incision type.

    Type of scalp incision during primary surgical intervention (flap or straight line incision).

    Measured: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.

  8. Skin closure techniques.

    Analysis of techniques used for scalp skin closure (continuous absorbable suture or interrupted non-absorbable sutures) during primary surgical intervention.

    Measured: From the enrollment till the end of observation period (6 weeks postoperatively).

  9. Cerebrospinal fluid leak occurrence timing.

    Time period between primary surgical intervention and cerebrospinal fluid leak occurrence.

    Measured: From the enrollment till the end of observation period (6 weeks postoperatively).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start3 Feb 2026
  3. Primary completionFeb 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
6 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT07411690
Sponsor's protocol ID
KB/147/2025
Acronym
CSF-IMR
Status last verified
Feb 2026
First submitted
8 Feb 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Tumor Adult and Brain Tumor Benign, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michal Senger, M.D. (+48 791 760 040, michal.senger@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cerebrospinal fluid leakage occurrence. (time frame: From the enrollment till the end of observation period (6 weeks postoperatively)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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