Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room

NCT03209804 | Completed DMC

• 1 other identifier: BJTTH-002
• Study Type: interventional
• Target: 519
• Locations: 1 country
• Sites: 4

Brief Summary

To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.

Conditions

Intracranial Arteriovenous Malformations

Keywords

Intracranial Arteriovenous Malformations

Outcome Measures

Primary Outcomes (4)

• Instant residual rate of AVMs

  The instant post-operative residual rate of AVMs

  up to 1 week after operation

• 3 months' residual rate of AVMs

  3 months' residual rate after AVM operation

  the date of 3rd month after operation, ±1 week

• 6 months' residual rate of AVMs

  6 months' residual rate after AVM operation

  the date of the 6th month after operation, ±1 week

• 1 year's residual rate of AVMs

  1 year's residual rate after AVM operation

  the date of the 12th month after operation, ±1 week

Secondary Outcomes (7)

• Morbidity rate of post-operative complications

  7 days after operation

• Post-operative mortality rate

  48 hours after operation

• Morbidity rate of neural functional deterioration-48 hours after operation

  the assessing time points is 48 hours after operation

• Morbidity rate of neural functional deterioration-1 week after operation

  1 week after operation

• Morbidity rate of neural functional deterioration-3 months after operation

  the 3rd month after operation, ±1 week

Study Arms (2)

Traditional neurosurgical techniques

OTHER

Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines.

Procedure: hybrid operating techniques

Hybrid operating techniques

EXPERIMENTAL

A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously

Procedure: hybrid operating techniques

Interventions

hybrid operating techniques PROCEDURE

A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.

Also known as: endovascular interventional embolisation, endovascular interventional balloon occlusion, microsurgical resection

Hybrid operating techniques; Traditional neurosurgical techniques

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly ruptured AVM with stable hematoma, selective operation is practical;
• with rupture history;
• recurrent epilepsy, failed in AED management;
• giant AVM with deterioration of neurological functions;
• grade AVM (Spetzler-Martin grading system) with no symptom and not located in eloquent area.

You may not qualify if:

• \>70 in age, with low rupture risk;
• newly ruptured AVM with unstable hematoma, engaged in emergency operation;
• ≥5 grade in Spetzler-Martin grading system;
• AVM located in hypothalamus, brainstem, cerebellopontine angle;
• cannot tolerant the operation;
• patient or relative refuses to participate the trail.

Sponsors & Collaborators

• Ministry of Science and Technology of the People´s Republic of China: lead
• Beijing Municipal Science & Technology Commission: collaborator

Study Sites (4)

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, 0086, China

Location

General Hospital of PLA

Beijing, Beijing Municipality, 100039, China

Location

Rocket Army General Hospital of PLA

Beijing, Beijing Municipality, 100088, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Intracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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: liuxingju

Model Details: Traditional therapy group：traditional management of AVMs, such as unsimultaneous endovascular interventional embolisation, radiotherapy followed by microsurgical resection, will be conducted to patients involved in this group. Hybrid operation group: A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously to patients in this group.

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 6, 2017
• Study Start: June 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: January 16, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

CN (4)