Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations
HOTAVM
Study on Benefits and Risks of Hybrid Operation in the Treatment of Complex Brain Arteriovenous Malformations
2 other identifiers
interventional
1,200
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 11, 2018
CompletedFirst Posted
Study publicly available on registry
December 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedDecember 12, 2018
December 1, 2018
4.8 years
December 11, 2018
December 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
neural function deterioration
Increasing of mRS and mRS\>2
3 months after operation
Secondary Outcomes (8)
neural function deterioration in 6 months
6 months after operation
neural function deterioration in 12 months
12 months after operation
postoperative mortality
7 days after operation
operation-related complications
7 days after operation
postoperative bAVMs residue
7 days after operation
- +3 more secondary outcomes
Study Arms (2)
Traditional microsurgery group
OTHERPatients 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.
Hybrid operation group
EXPERIMENTALPatients receive microsurgical operation under the assistance of intraoperative DSA, endovascular embolization and/or balloon occlusion in the one-staged hybrid operating theater.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \>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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053, China
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, 100070, China
General Hospital of Rocket Army
Beijing, Beijing Municipality, 100088, China
Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266034, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Related Publications (2)
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.
PMID: 31359304DERIVEDWang 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.
PMID: 31039755DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shuo Wang, MD
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Neurosurgery Department
Study Record Dates
First Submitted
December 11, 2018
First Posted
December 12, 2018
Study Start
January 1, 2016
Primary Completion
October 1, 2020
Study Completion
December 31, 2020
Last Updated
December 12, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share