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

NCT07195786 | Not Yet Recruiting DMC

• 1 other identifier: 2025-230
• Study Type: observational
• Target: 356
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Expansion-floating Craniotomy; Malignant Cerebral Edema; decompressive craniectomy; Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Functional outcomes assessed by the modified Rankin Scale (mRS) were dichotomized into scores 0-4 versus 5 and 6

  3 months

Secondary Outcomes (7)

• Median survival time

  3 months

• Overall mortality

  3 months

• Time interval from initial surgery to bone flap reimplantation or Expansion-Suspension Technique fixation (if applicable)

  3 months

• Incidence of procedure-related complications

  3 months

• The Short-From-36 Health Survey（SF-36）

  3 months

Study Arms (3)

Treatment group

Expansion-floating Craniotomy (EC) is performed, preserving the bone flap, while suspending it above the skull using specific fixation devices.

Procedure: Expansion-floating Craniotomy

Standard treatment control group

Decompressive Craniectomy (DC) is performed, removing a section of skull bone to reduce intracranial pressure (ICP).

Procedure: decompressive craniectomy

Conservative treatment group

Conservative pharmacological therapy was administered instead, as surgical intervention indicated per guidelines was refused by the patient or family.

Drug: drug conservative therapeutic

Interventions

Expansion-floating Craniotomy PROCEDURE

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.

Treatment group

decompressive craniectomy PROCEDURE

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.

Standard treatment control group

drug conservative therapeutic DRUG

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

Conservative treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects developing malignant cerebral edema after acute cerebral infarction

You may qualify if:

• Age requirement: Adults aged \>18 but \<80 years
• Acute cerebral infarction diagnosis: Patients with internal carotid artery or middle cerebral artery occlusion within 48 hours, meeting all three criteria:
• NIHSS score ≥16 with item 1a (level of consciousness) ≥1 CT demonstrating \>50% MCA territory infarction or hypoperfused area \>2/3, OR DWI hyperintensity volume \>82 ml within 6 hours of onset, OR DWI infarct volume \>145 ml within 14 hours
• Imaging evidence: Midline shift ≥5 mm to the contralateral side on CT, OR significant ipsilateral ventricular compression with effacement of cerebral sulci/cisterns.

You may not qualify if:

• Pre-stroke mRS score ≥1
• Significant contralateral cerebral infarction
• Symptomatic intracranial hemorrhage
• Any known coagulopathy
• Life expectancy \<3 years
• Any severe comorbidities potentially interfering with treatment evaluation

Sponsors & Collaborators

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

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Decompressive Craniectomy

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Decompression, Surgical; Surgical Procedures, Operative; Craniotomy; Neurosurgical Procedures

Central Study Contacts

Meng Zhang, Chief Physician, Professor

CONTACT

86+13708332600; zhangmeng861@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share