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

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

Status: Unknown

Conditions: Arteriovenous Malformations; Cerebrovascular Disease; Complex; Primary

Treatments: Procedure: one-staged hybrid operation; Procedure: Traditional microsurgical operation

Study type: Interventional

Funder types: Other

Identifiers

NCT03774017

BJTTH-007

2016YFC1301801 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

Traditional microsurgery group

Other group

Description:

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.

Treatment:

Procedure: Traditional microsurgical operation

Hybrid operation group

Experimental group

Description:

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

Treatment:

Procedure: one-staged hybrid operation