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

Not Applicable

• Conditions: Complex; Primary; Arteriovenous Malformations; Cerebrovascular Disease
• Interventions: Procedure: one-staged hybrid operation; Procedure: Traditional microsurgical operation

• Registration Number: NCT03774017
• Lead Sponsor: Ministry of Science and Technology of the People´s Republic of China

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Last Update Submitted: 2018-12-11
• Study First Posted: 2018-12-12
• Last Update Posted: 2018-12-12
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid operation group	one-staged hybrid operation	Patients receive microsurgical operation under the assistance of intraoperative DSA, endovascular embolization and/or balloon occlusion in the one-staged hybrid operating theater.
Traditional microsurgery group	Traditional microsurgical operation	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.

Primary Outcome Measures

Name	Time	Method
neural function deterioration	3 months after operation	Increasing of mRS and mRS\>2

Secondary Outcome Measures

Name	Time	Method
postoperative mortality	7 days after operation	the fatality due to operation
operation-related complications	7 days after operation	any complications that occur within 7 days from the date of operation, including intracranial hemorrhage or infarction, infection of the central nervous system, infection of the respiratory system, cranial nerve deficits, and other symptomatic complications
neural function deterioration in 12 months	12 months after operation	Increasing of mRS and mRS\>2
neural function deterioration in 6 months	6 months after operation	Increasing of mRS and mRS\>2
postoperative bAVMs residue	7 days after operation	the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
3 months bAVMs residue	3 months after operation	the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
6 months bAVMs residue	6 months after operation	the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
12 months bAVMs residue	12 months after operation	the bAVMs residue revealed by postoperative DSA or computed tomographic angiography

Trial Locations

Locations (7)

Huashan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

General Hospital of Rocket Army; 🇨🇳 Beijing, Beijing, China

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Beijing Tiantan Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

Qingdao Municipal Hospital; 🇨🇳 Qingdao, Shandong, China