Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room

NCT ID: NCT03209804

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 519 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-01-16

Brief Summary

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

Detailed 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.

Conditions

Intracranial Arteriovenous Malformations

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional neurosurgical techniques

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

Group Type: OTHER

hybrid operating techniques

Intervention Type: PROCEDURE

A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.

Hybrid operating techniques

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

Group Type: EXPERIMENTAL

hybrid operating techniques

Intervention Type: PROCEDURE

A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.

Interventions

hybrid operating techniques

A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.

Intervention Type: PROCEDURE

Other Intervention Names

endovascular interventional embolisation; endovascular interventional balloon occlusion; microsurgical resection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Shuo Wang

liuxingju

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, China

General Hospital of PLA

Beijing, Beijing Municipality, China

Rocket Army General Hospital of PLA

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

BJTTH-002

Identifier Type: -

Identifier Source: org_study_id