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NCT Number: NCT07411690

Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Surgical site infections incidence.

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

    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).

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. Antibiotic therapy.

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

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

  6. Dura restoration techniques.

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

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

  7. Scalp incision type.

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

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

  8. Skin closure techniques.

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

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

  9. Cerebrospinal fluid leak occurrence timing.

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Michal Senger, M.D.

CONTACT

[email protected]

+48 791 760 040

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Acronym: CSF-IMR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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