Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors (CSF-IMR)

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.

Study Overview

• Status: Recruiting
• Conditions: Glioma; Glioblastoma; Meningioma; Craniotomy; Brain Tumor Adult; Brain Tumor Benign; CerebroSpinal Fluid (CSF) Leak

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Michal Senger, M.D.; Phone Number: +48 791 760 040; Email: michal.senger@wum.edu.pl

Study Locations

• Poland
  • Warsaw, Poland, 02-097
    • Recruiting
    • Department of Neurosurgery of Medical Univeristy of Warsaw
    • Contact: Michal Senger, M.D.; Phone Number: +48 791 760 040; Email: michal.senger@wum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients qualified for supratentorial craniotomy for intracranial tumor.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the enrollment till the end of observation period (6 weeks postoperatively)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	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.	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).	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.	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.	From the enrollment till the end of observation period (6 weeks postoperatively).

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Tomasz A Dziedzic, M.D. PhD, Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland; Principal Investigator: Michal Senger, M.D., Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: glioma; meningioma; supratentorial craniotomy; cerebrospinal fluid leak; intracranial tumor
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Craniocerebral Trauma; Trauma, Nervous System; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Glioblastoma; Glioma; Meningioma; Brain Neoplasms; Cerebrospinal Fluid Leak
• Other Study ID Numbers: KB/147/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No