Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors

NCT07411690 | Recruiting

• 1 other identifier: KB/147/2025
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Brain Tumor Adult; Craniotomy; Glioblastoma; Glioma; Meningioma; Brain Tumor Benign; CerebroSpinal Fluid (CSF) Leak

Keywords

intracranial tumor; cerebrospinal fluid leak; supratentorial craniotomy; glioma; meningioma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

• Surgical site infections incidence.

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

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

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

• Hospitalization 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.

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

• Antibiotic therapy.

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

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

Patients qualified for supratentorial craniotomy for intracranial tumor.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Neurosurgery of Medical Univeristy of Warsaw

Warsaw, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Glioblastoma; Glioma; Meningioma; Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Michal Senger, M.D.

  Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

• Tomasz A Dziedzic, M.D. PhD

  Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Senger, M.D.

CONTACT

+48 791 760 040; michal.senger@wum.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 17, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-02

Locations

PL (1)