Expansion-floating Craniotomy for the Treatment of Malignant Cerebral Edema Caused by Acute Ischemic Stroke

Summary

This clinical study investigates Expansion-floating Craniotomy (EC), a novel surgical technique for treating life-threatening malignant cerebral edema following large hemispheric infarction (commonly known as massive stroke). Malignant edema causes rapid increases in intracranial pressure, compressing vital brain structures and risking fatal brain herniation, requiring urgent intervention.

The current international standard treatment is traditional decompressive craniectomy (DC). DC involves removing a section of the skull to allow brain swelling, effectively reducing pressure and mortality risk. It is strongly recommended (Class I, Level A evidence) in major guidelines. However, DC typically requires a second major surgery (cranioplasty) approximately 3 months later to replace the removed bone flap, involving additional costs and risks like progressive intracranial hemorrhage or subdural hygroma.

EC is a newer approach designed to potentially eliminate the need for a second surgery. During EC, surgeons use medical titanium plates to temporarily elevate the bone flap, creating immediate space for brain swelling while keeping the bone flap attached. Once brain swelling subsides (usually within weeks), a minor procedure flattens the titanium plates, allowing the patient's own bone to naturally reposition without requiring cranioplasty. EC may be performed based on surgeon assessment of brain swelling, guideline considerations, or experience. If EC is deemed unsuitable during surgery, DC will be performed instead.

While early research suggests EC achieves decompression similar to DC while preserving the bone flap, its safety and effectiveness compared to the established DC procedure are not yet fully proven. DC is a well-understood, mature technique with known risks and benefits, including the certainty of needing cranioplasty. Conservative management is reserved for patients unfit for surgery but may not prevent neurological deterioration.This study aims to conduct a preliminary assessment of the outcomes of EC versus DC.

Conditions

• Ischemic Stroke, Acute
• Malignant Cerebral Edema

Interventions

PROCEDURE

Expansion-floating Craniotomy

Following craniotomy with bone flap removal, cerebral edema is assessed. The bone flap is then elevated using 2-3 titanium connectors. The elevation height must be sufficient to at least prevent contact between the bone flap and the underlying brain tissue. If cerebral swelling proves less severe than anticipated or begins to subside, the connectors can be loosened minimally invasively after a maximum scalp expansion period of 7-10 days. The elevated bone flap gradually repositions itself. Mild compression is applied using an elastic bandage for fixation, thereby restoring cranial integrity.

PROCEDURE

decompressive craniectomy

The patient is placed supine with the head rotated contralaterally. A large retroauricular question-mark incision is made in the scalp. Alternatively, a Kempe incision or preauricular incision may be used according to surgeon preference. Meticulous preservation of the superficial temporal artery (STA) is essential during the procedure to prevent ischemic complications in the flap. After elevating the myocutaneous flap to expose the operative field, a fronto-temporo-parietal craniectomy is performed. For unilateral decompressive craniectomy, the bone window should measure at least 15 × 12 cm, extending inferiorly to the floor of the temporal fossa to ensure adequate decompression.

DRUG

drug conservative therapeutic

Pharmacotherapy for malignant cerebral edema has been implemented according to current guidelines.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2027-03-30

Completion

2027-05-30