Comparison of Clipping Via Keyhole Versus Traditional Approaches and Coiling for Ruptured Aneurysms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2018-12-31

Brief Summary

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Endovascular coiling has become a strategy of choice of intracranial aneurysms due to its minimally invasiveness. However, there has few prospective randomized controlled studies on the comparison of therapeutic effect between endovascular coiling and microsurgical clipping, especially the latter via keyhole approaches, which has been widely used in recent years. Based on the data of a single center, a randomized controlled study was conducted on patients with ruptured anterior circulation aneurysms suitable for both endovascular and extravascular treatment, including endovascular coiling, microsurgical clipping via conventional craniotomy and keyhole approaches, in order to compare the efficacy of the above strategies and provide more objective basis for treatment selection for operators.

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Detailed Description

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Consecutive patients of a single center will be screened. If spontaneous subarachnoid hemorrhage (SAH) is confirmed by head computed tomography (CT), a diagnostic CT angiography (CTA) or digital subtraction angiography (DSA) will be carried out emergently. A patients harbored a single intracranial aneurysm of anterior circulation that resulted in SAH will be concerned. Based on the assessment of condition, the patient will enrolled into this study without indication of decompressive craniectomy. The enrolled patients will be divided randomly into 3 groups, who experienced endovascular coiling, microsurgical clipping via conventional craniotomy and via keyhole approaches. All of these treatment will be conducted by a same senior neurosurgeon. CTA or DSA were followed up regularly. The occlusion rate, operative period, hospitalization duration and cost, surgical complications were compared and analyzed.

Conditions

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Randomized Controlled Trial Intracranial Aneurysm Microsurgery Endovascular Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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keyhole group

patient harbored aneurysm who was treated by microsurgical clipping via keyhole approach.

Group Type EXPERIMENTAL

keyhole microneurosurgery

Intervention Type PROCEDURE

microsurgical clipping via keyhole approach

conventional group

patient harbored aneurysm who was treated by microsurgical clipping via conventional craniotomy.

Group Type EXPERIMENTAL

conventional microneurosurgery

Intervention Type PROCEDURE

microsurgical clipping via conventional craniotomy

endovascular group

patient harbored aneurysm who was treated by endovascular coiling via femoral approach.

Group Type EXPERIMENTAL

endovascular coiling

Intervention Type PROCEDURE

endovascular coiling via femoral approach

Interventions

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keyhole microneurosurgery

microsurgical clipping via keyhole approach

Intervention Type PROCEDURE

conventional microneurosurgery

microsurgical clipping via conventional craniotomy

Intervention Type PROCEDURE

endovascular coiling

endovascular coiling via femoral approach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Single intracranial anterior circulation aneurysm diagnosed by CTA or DSA
* CT showed that subarachnoid hemorrhage originated from the rupture of the aneurysm and was confirmed during operation
* No indication of decompressive craniectomy (Hunt-Hess grade ≤ 4, Glasgow Coma Scale ≥ 7, no brain herniation; CT showed midline displacement \< 5mm)
* The aneurysm is suitable for both endovascular treatment and microsurgical clipping

Exclusion Criteria

* The patients and their families did not agree to join the study
* Patients with unruptured anterior circulation aneurysms
* Patients with posterior circulation aneurysms
* Patients with multiple intracranial aneurysms
* Those who cannot receive treatment due to serious concomitant diseases

Eligible Sex

ALL

Accepts Healthy Volunteers

No