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

Sponsor

Ministry of Science and Technology of the People´s Republic of China (Other)

Overall Status

Unknown status

CT.gov ID

NCT03774017

Collaborator

(none)

1,200

Enrollment

Locations

Arms

Anticipated Duration (Months)

171.4

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Disease Arteriovenous Malformations Complex; Primary	Procedure: one-staged hybrid operation Procedure: Traditional microsurgical operation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Study on Benefits and Risks of Hybrid Operation in the Treatment of Complex Brain Arteriovenous Malformations

Actual Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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
Experimental: 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.	Procedure: 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.

Arm

Intervention/Treatment

Other: 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.

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

Experimental: 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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

neural function deterioration [3 months after operation]
Increasing of mRS and mRS>2

Secondary Outcome Measures

neural function deterioration in 6 months [6 months after operation]
Increasing of mRS and mRS>2
neural function deterioration in 12 months [12 months after operation]
Increasing of mRS and mRS>2
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients of all ages;
diagnosed with arteriovenous malformations (AVMs) in brain parenchyma (including cerebrum and cerebellum) by DSA, with/without dura arteriovenous fistula;
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;
with Spetzler-Martin Grades from I to IV;
who provide informed consent.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital, Capital Medical University	Beijing	Beijing	China	100053
2	Beijing Tiantan Hospital Capital Medical University	Beijing	Beijing	China	100070
3	General Hospital of Rocket Army	Beijing	Beijing	China	100088
4	Qilu Hospital, Shandong University	Jinan	Shandong	China	250012
5	Qingdao Municipal Hospital	Qingdao	Shandong	China	266034
6	Huashan Hospital, Fudan University	Shanghai	Shanghai	China	200040
7	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009