Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room (SMAVMHR)

Ministry of Science and Technology of the People´s Republic of China

Status: Completed

Conditions: Intracranial Arteriovenous Malformations

Treatments: Procedure: hybrid operating techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT03209804

BJTTH-002

Details and patient eligibility

About

To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.

Full description

Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations(AVMs). Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.

Objects: Patients with cerebral arteriovenous malformations, coincident with inclusion and exclusion criterion and admitted in participating organizations.

Methods: Patients will be distributed into 2 groups, including traditional therapy group(control group) and hybrid operating group(trial group), and conduct with traditional neurosurgical management or one-stage hybrid operating management correspondingly. Residual rate of AVM is considered to be the primary observing indicator, and morbidity rate of post-operative complications, post-operative mortality rate, and morbidity rate of neural functional deterioration are secondary indicators.The information of operations will be recorded in detail as evidence of optimization of workflow and technical key knots.

Enrollment: 519 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• newly ruptured AVM with stable hematoma, selective operation is practical;
• with rupture history;
• recurrent epilepsy, failed in AED management;
• giant AVM with deterioration of neurological functions;
• 1-4 grade AVM (Spetzler-Martin grading system) with no symptom and not located in eloquent area.

Exclusion criteria

• >70 in age, with low rupture risk;
• newly ruptured AVM with unstable hematoma, engaged in emergency operation;
• ≥5 grade in Spetzler-Martin grading system;
• AVM located in hypothalamus, brainstem, cerebellopontine angle;
• cannot tolerant the operation;
• patient or relative refuses to participate the trail.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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519 participants in 2 patient groups

Traditional neurosurgical techniques

Other group

Description:

Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines.

Treatment:

Procedure: hybrid operating techniques

Hybrid operating techniques

Experimental group

Description:

A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously

Treatment:

Procedure: hybrid operating techniques