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

Primary Purpose

Cerebrovascular Disease, Arteriovenous Malformations, Complex; Primary

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
one-staged hybrid operation
Traditional microsurgical operation
Sponsored by
Ministry of Science and Technology of the People´s Republic of China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Disease focused on measuring brain arteriovenous malformations, one-staged hybrid operation

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xuanwu Hospital, Capital Medical UniversityRecruiting
  • Beijing Tiantan Hospital Capital Medical UniversityRecruiting
  • General Hospital of Rocket ArmyRecruiting
  • Qilu Hospital, Shandong UniversityRecruiting
  • Qingdao Municipal HospitalRecruiting
  • Huashan Hospital, Fudan UniversityRecruiting
  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Traditional microsurgery group

Hybrid operation group

Arm 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.

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

Outcomes

Primary Outcome Measures

neural function deterioration
Increasing of mRS and mRS>2

Secondary Outcome Measures

neural function deterioration in 6 months
Increasing of mRS and mRS>2
neural function deterioration in 12 months
Increasing of mRS and mRS>2
postoperative mortality
the fatality due to 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
postoperative bAVMs residue
the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
3 months bAVMs residue
the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
6 months bAVMs residue
the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
12 months bAVMs residue
the bAVMs residue revealed by postoperative DSA or computed tomographic angiography

Full Information

First Posted
December 11, 2018
Last Updated
December 11, 2018
Sponsor
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT03774017
Brief Title
Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations
Acronym
HOTAVM
Official Title
Study on Benefits and Risks of Hybrid Operation in the Treatment of Complex Brain Arteriovenous Malformations
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disease, Arteriovenous Malformations, Complex; Primary
Keywords
brain arteriovenous malformations, one-staged hybrid operation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional microsurgery group
Arm Type
Other
Arm 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.
Arm Title
Hybrid operation group
Arm Type
Experimental
Arm Description
Patients receive microsurgical operation under the assistance of intraoperative DSA, endovascular embolization and/or balloon occlusion in the one-staged hybrid operating theater.
Intervention Type
Procedure
Intervention Name(s)
one-staged hybrid operation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Traditional microsurgical operation
Intervention Description
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
Primary Outcome Measure Information:
Title
neural function deterioration
Description
Increasing of mRS and mRS>2
Time Frame
3 months after operation
Secondary Outcome Measure Information:
Title
neural function deterioration in 6 months
Description
Increasing of mRS and mRS>2
Time Frame
6 months after operation
Title
neural function deterioration in 12 months
Description
Increasing of mRS and mRS>2
Time Frame
12 months after operation
Title
postoperative mortality
Description
the fatality due to operation
Time Frame
7 days after operation
Title
operation-related complications
Description
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
Time Frame
7 days after operation
Title
postoperative bAVMs residue
Description
the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
Time Frame
7 days after operation
Title
3 months bAVMs residue
Description
the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
Time Frame
3 months after operation
Title
6 months bAVMs residue
Description
the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
Time Frame
6 months after operation
Title
12 months bAVMs residue
Description
the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
Time Frame
12 months after operation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuo Wang, MD
Phone
861059976510
Email
captain9858@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Wu, MD
Phone
861059976510
Email
wujunslf@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuo Wang, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guilin Li, MD
Phone
861083198899
Facility Name
Beijing Tiantan Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuo Wang, MD
Phone
861059976510
Email
captain9858@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Jun Wu, MD
Phone
861059976510
Email
wujunslf@126.com
Facility Name
General Hospital of Rocket Army
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100088
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weijian Jiang, MD
Phone
861066343337
Facility Name
Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donghai Wang, MD
Phone
8653182166173
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuanfeng Li, MD
Phone
8653282789017
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Chen, MD
Phone
860215288999
Email
chenlianghs@126.com
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gao Chen, MD
Phone
8657187783777

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31359304
Citation
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.
Results Reference
derived
PubMed Identifier
31039755
Citation
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.
Results Reference
derived

Learn more about this trial

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

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