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.
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
- Conditions the study is for
- Brain Tumor Adult, Brain Tumor Benign, CerebroSpinal Fluid (CSF) Leak
- 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.
Poland1 site, 1 recruiting
- 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
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.
- Conditions
- Brain Tumor Adult, Brain Tumor Benign, CerebroSpinal Fluid (CSF) Leak, Craniotomy, Glioblastoma, Glioma
- 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 group | Role | What they receive |
|---|---|---|
| Patients qualified for a supratentorial craniotomy for intracranial tumor | Patients 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.
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)
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).
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.
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.
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.
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.
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).
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.
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).
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.
- First posted17 Feb 2026
- Study start3 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor AdultStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michal Senger, M.D., Principal investigator, Department of Neurosurgery, Medical University of Warsaw, Warsaw, PolandTomasz A Dziedzic, M.D. PhD, Principal investigator, Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrospinal Fluid Leak Incidence, Management and Risk Factor After Supratentorial Craniotomy for Intracranial Tumors: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT07411690
- Acronym / sponsor ID
- CSF-IMR / KB/147/2025
- Conditions
- Brain Tumor Adult, Brain Tumor Benign, CerebroSpinal Fluid (CSF) Leak, Craniotomy, Glioblastoma, Glioma
- Keywords
- intracranial tumor, cerebrospinal fluid leak, supratentorial craniotomy, glioma, meningioma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients qualified for a supratentorial craniotomy for intracranial tumor | – | –Patients who are qualified for a supratentorial craniotomy for intracranial tumor who need neither urgent neurosurgical treatment or secondary surgery due to tumor progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients qualified for supratentorial craniotomy for intracranial tumor.
Key inclusion criteria (2 listed)
- Male or female at least 18 years old
- Qualified for a craniotomy due to supratentorial intracranial tumor
Key exclusion criteria (2 listed)
- Revision surgery due to recurrent brain tumor
- Emergency neurosurgical procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cerebrospinal fluid leakage occurrence.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively)
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.
9 secondary outcomes
Surgical site infections incidence.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively).
Unplanned outpatient clinic or emergency department visits due to cerebrospinal fluid leak.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.
Hospitalization due to cerebrospinal fluid leak.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.
Treatment modalities of cerebrospinal fluid leak.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.
Antibiotic therapy.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.
Dura restoration techniques.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively).
Scalp incision type.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively) or resolution of cerebrospinal fluid leak.
Skin closure techniques.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively).
Cerebrospinal fluid leak occurrence timing.
Time frame: From the enrollment till the end of observation period (6 weeks postoperatively).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michal Senger, M.D. principal investigator
Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland
Tomasz A Dziedzic, M.D. PhD principal investigator
Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland
1 site in 1 country: see every site and its status.
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.