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

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.

Study Overview

• Status: Unknown
• Conditions: Arteriovenous Malformations; Cerebrovascular Disease; Complex; Primary
• Intervention / Treatment: Procedure: Traditional microsurgical operation; Procedure: one-staged hybrid operation

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 Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuo Wang, MD; Phone Number: 861059976510; Email: captain9858@vip.sina.com
• Study Contact Backup: Name: Jun Wu, MD; Phone Number: 861059976510; Email: wujunslf@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Guilin Li, MD; Phone Number: 861083198899
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital Capital Medical University
      • Contact: Shuo Wang, MD; Phone Number: 861059976510; Email: captain9858@vip.sina.com
      • Contact: Jun Wu, MD; Phone Number: 861059976510; Email: wujunslf@126.com
    • Beijing, Beijing, China, 100088
      • Recruiting
      • General Hospital of Rocket Army
      • Contact: Weijian Jiang, MD; Phone Number: 861066343337
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital, Shandong University
      • Contact: Donghai Wang, MD; Phone Number: 8653182166173
    • Qingdao, Shandong, China, 266034
      • Recruiting
      • Qingdao Municipal Hospital
      • Contact: Chuanfeng Li, MD; Phone Number: 8653282789017
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital, Fudan University
      • Contact: Liang Chen, MD; Phone Number: 860215288999; Email: chenlianghs@126.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Gao Chen, MD; Phone Number: 8657187783777

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neural function deterioration	Increasing of mRS and mRS>2	3 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neural function deterioration in 6 months	Increasing of mRS and mRS>2	6 months after operation
neural function deterioration in 12 months	Increasing of mRS and mRS>2	12 months after operation
postoperative mortality	the fatality due to operation	7 days after operation
operation-related complications	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	7 days after operation
postoperative bAVMs residue	the bAVMs residue revealed by postoperative DSA or computed tomographic angiography	7 days after operation
3 months bAVMs residue	the bAVMs residue revealed by postoperative DSA or computed tomographic angiography	3 months after operation
6 months bAVMs residue	the bAVMs residue revealed by postoperative DSA or computed tomographic angiography	6 months after operation
12 months bAVMs residue	the bAVMs residue revealed by postoperative DSA or computed tomographic angiography	12 months after operation

Collaborators and Investigators

• Sponsor: Ministry of Science and Technology of the People´s Republic of China
• Investigators: Principal Investigator: Shuo Wang, MD, Beijing Tiantan Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: brain arteriovenous malformations; one-staged hybrid operation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Cardiovascular Abnormalities; Neoplasms, Vascular Tissue; Vascular Malformations; Congenital Abnormalities; Hemangioma; Arteriovenous Malformations; Cerebrovascular Disorders
• Other Study ID Numbers: BJTTH-007; 2016YFC1301801 (Other Grant/Funding Number: National Key Technologies R&D Program of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No