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Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations

NCT ID: NCT03774017

Last Updated: 2018-12-12

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2020-12-31

Brief Summary

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Complex brain arteriovenous malformations (bAVMs) in ≥3 Spetzler-Martin grades have long been challenges among cerebrovascular diseases. None of the traditional methods, such as microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can completely eliminate complex bAVMs without a risk of neural function deterioration. The multistaged hybrid operation solved part of the challenge but remained risky in the installment procedures and intervals. The one-staged hybrid operation was applied in the surgical treatment of cerebrovascular diseases and proved to be a potentially safe and effective method for curing complex bAVMs. However, lacking the support of high-level evidence, its advantages remain unclear. This study was proposed to validate the benefits and risks of one-staged hybrid operation in the treatment of complex bAVMs, as well as its indications, key technologies, and workflows.

Detailed Description

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The study is being conducted from Jan 2016 to Dec 2020 with 20 cooperation units. It consists of 2 sets. The registry set is designed as a prospective real-world registry. The trial set is designed as a prospective pragmatic clinical trial, specifically for the patients with perforating arterial feeders. The two sets share a common grouping: the traditional operation group and the one-staged hybrid operation group. The assignment is based on the clinical condition in the registry set and is randomized in the trial set. End points will be evaluated at scheduled time points. The safety and efficiency of one-staged hybrid operation in treating complex bAVMs will be validated.

Conditions

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Cerebrovascular Disease Arteriovenous Malformations Complex; Primary

Keywords

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brain arteriovenous malformations one-staged hybrid operation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Traditional microsurgery group

Patients receive only traditional microsurgical operations in traditional operating theaters or the one-staged hybrid operation theater. No endovascular intervention technique or intraoperative digital subtraction angiography(DSA) will be performed. The DSA will be performed in 3 days after the operation.

Group Type OTHER

Traditional microsurgical operation

Intervention Type PROCEDURE

The classical mode of operations in neurosurgery. The operation is performed with neurosurgical instruments and microscope. Some of assisting tools can be used in the operation, such as neuro-navigation, Doppler probe, neural electrophysiological monitoring and so on. But neither the intraoperative DSA nor endovascular intervention techniques is used in the operation

Hybrid operation group

Patients receive microsurgical operation under the assistance of intraoperative DSA, endovascular embolization and/or balloon occlusion in the one-staged hybrid operating theater.

Group Type EXPERIMENTAL

one-staged hybrid operation

Intervention Type PROCEDURE

An integrated procedure that consists of microsurgery, intraoperative DSA, endovascular intervention techniques and other assistance tools. All the procedures are performed in a one-staged operation without any intermission or any transfer of patients.

Interventions

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one-staged hybrid operation

An integrated procedure that consists of microsurgery, intraoperative DSA, endovascular intervention techniques and other assistance tools. All the procedures are performed in a one-staged operation without any intermission or any transfer of patients.

Intervention Type PROCEDURE

Traditional microsurgical operation

The classical mode of operations in neurosurgery. The operation is performed with neurosurgical instruments and microscope. Some of assisting tools can be used in the operation, such as neuro-navigation, Doppler probe, neural electrophysiological monitoring and so on. But neither the intraoperative DSA nor endovascular intervention techniques is used in the operation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. patients of all ages;
2. diagnosed with arteriovenous malformations (AVMs) in brain parenchyma (including cerebrum and cerebellum) by DSA, with/without dura arteriovenous fistula;
3. with any operative indications as follows: (1) with stable hematoma or history of hemorrhage due to bAVMs, and allowed selective operation; (2) with recurrent epilepsy seizure, having failed treatment with antiepileptic drugs (AEDs); (3) with induced deterioration of neurological functions;
4. with Spetzler-Martin Grades from I to IV;
5. who provide informed consent.

Exclusion Criteria

1. \>70 years old with no significant hemorrhagic risk of bAVMs;
2. with Spetzler-Martin Grade ≥V;
3. accompanied by severe chronic disease, organ dysfunction, or malignant tumor that cannot tolerate the operation;
4. allergic to iodinated contrast agent;
5. unable to give informed consent.
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Shuo Wang

Director of Neurosurgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuo Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

General Hospital of Rocket Army

Beijing, Beijing Municipality, China

Site Status RECRUITING

Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, China

Site Status RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuo Wang, MD

Role: CONTACT

Phone: 861059976510

Email: [email protected]

Jun Wu, MD

Role: CONTACT

Phone: 861059976510

Email: [email protected]

Facility Contacts

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Guilin Li, MD

Role: primary

Shuo Wang, MD

Role: primary

Jun Wu, MD

Role: backup

Weijian Jiang, MD

Role: primary

Donghai Wang, MD

Role: primary

Chuanfeng Li, MD

Role: primary

Liang Chen, MD

Role: primary

Gao Chen, MD

Role: primary

References

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Wang M, Qiu H, Cao Y, Wang S, Zhao J. One-staged in situ embolization combined with surgical resection for eloquence protection of AVM: technical note. Neurosurg Rev. 2019 Sep;42(3):783-790. doi: 10.1007/s10143-019-01137-w. Epub 2019 Jul 30.

Reference Type DERIVED
PMID: 31359304 (View on PubMed)

Wang M, Jiao Y, Cao Y, Wang S, Zhao J. Surgical management of complex brain arteriovenous malformations with hybrid operating technique: study protocol of a prospective registry and a pragmatic clinical trial. BMC Neurol. 2019 Apr 30;19(1):75. doi: 10.1186/s12883-019-1289-3.

Reference Type DERIVED
PMID: 31039755 (View on PubMed)

Other Identifiers

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2016YFC1301801

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BJTTH-007

Identifier Type: -

Identifier Source: org_study_id