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Multimodal neuronavigation-guided precision bypass in adult ischaemic patients with moyamoya disease: study protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Revascularisation surgery is an important treatment of moyamoya disease (MMD). Several general methods of revascularisation had been used: direct, indirect and combined techniques. However, there had been no reports about the criteria of recipient arteries selection in bypass surgery for MMD. Surgeons usually choose the recipient arteries by their own experiences. Their choices of the recipient arteries are various and may contribute the different outcome of patients. The purpose is to identify utility and efficacy of precision bypass guided by multimodal neuronavigation of MMD in a prospective randomised controlled trial. METHOD AND ANALYSIS:This study is a prospective randomised controlled clinical trial. This study will enrol a total of 100 eligible patients. These eligible patients will be randomised to the empirical bypass group and the multimodal neuronavigation-guided precision bypass group in a 1:1 ratio. Patient baseline characteristics and MMD characteristics will be described. In the multimodal neuronavigation-guided group, the blood velocity and blood flow of the recipient arteries will be identified. Surgical complications and outcomes at pretreatment, post-treatment, at discharge and at 3?month, 6?month, 12?month and end of trial will be analysed with CT perfusion, MRI, digital subtraction angiography, modified Rankin Scale, National Institute of Health Stroke Scale and modified Barthel Scale. This trial will determine whether multimodal neuronavigation-guided precision bypass is superior to empirical bypass in patients with MMD and identify the safety and efficacy of multimodal neuronavigation-guided precision bypass. ETHICS AND DISSEMINATION:The study protocol and written informed consent were reviewed and approved by the Clinical Research Ethics Committee of Peking University International Hospital. Study findings will be disseminated in the printed media. The study started in August, 2018 and expected to be completed in December, 2020. TRIAL REGISTRATION NUMBER:NCT03516851; Pre-results.

SUBMITTER: Lu J

PROVIDER: S-EPMC6475208 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Multimodal neuronavigation-guided precision bypass in adult ischaemic patients with moyamoya disease: study protocol for a randomised controlled trial.

Lu Junlin J Zhao Yahui Y Ma Li L Chen Yu Y Li Mingtao M Ye Xun X Wang Rong R Chen Xiaolin X Zhao Yuanli Y

BMJ open 20190320 3

<h4>Introduction</h4>Revascularisation surgery is an important treatment of moyamoya disease (MMD). Several general methods of revascularisation had been used: direct, indirect and combined techniques. However, there had been no reports about the criteria of recipient arteries selection in bypass surgery for MMD. Surgeons usually choose the recipient arteries by their own experiences. Their choices of the recipient arteries are various and may contribute the different outcome of patients. The pu ...[more]

PMID: 30898819

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Project description:Objective: Extracranial-intracranial bypass is currently recognized as the optimal treatment for hemorrhagic-type moyamoya disease (MMD) which reduces incidence of rebleeding. Recent studies have reported the advantage of combined bypass over direct bypass for the general MMD patients. However, the effect of direct bypass and combined bypass surgery specifically for hemorrhagic-type MMD had not been investigated yet. Methods: Hemorrhagic-type MMD patients who underwent direct and combined bypass surgery with complete clinical and radiological documentation from a multicenter cohort between 2009 and 2017 were retrospectively included. Surgical methods included superficial temporal artery-middle cerebral artery (STA-MCA) anastomosis (direct bypass), combined STA-MCA bypass with encephalodurosynangiosis (EDS), and combined STA-MCA bypass with encephaloduroarteriosynangiosis (EDAS). Matsushima standard on follow-up catheter angiography was used to assess surgical outcome. Modified Rankin Scale, incidence of rebleeding and ischemia during follow-up were recorded. Rebleeding-free survival rates between direct and combined bypass were compared by Kaplan-Meier analysis. Results: Sixty eight hemorrhagic-onset MMD patients were included in this study, among which 71 hemispheres were treated with surgery (direct bypass: 17; bypass+EDS: 24; bypass+EDAS: 30). Forty six (64.8%) hemispheres had satisfactory revascularization (Matsushima level 2-3) and 26 (36.6%) had poor neoangiogenesis. Matsushima level was not significantly different between surgical groups (P = 0.258). Good neoangiogenesis from dural grafts was achieved in 26 (36.6%) hemispheres, and good neoangiogenesis from STA grafts was only seen in 4 (out of 30, 12.5%) hemispheres. Multivariate analysis showed bypass patency [P < 0.001, OR (95%CI): 13.41 (3.28-54.80)] and dural neoangiogenesis [P < 0.001, OR (95%CI): 13.18 (3.26-53.36)] both independently contributed to good angiographic outcome. During follow-up, incidences of rebleeding or ischemic events, and re-bleeding free survival rate were not significantly different between surgical groups (P = 0.433, P = 0.559, and P = 0.997). However, patients who underwent combined bypass surgery had significantly lower mRS at follow-up comparing to patients who underwent direct bypass (P = 0.006). Conclusion: Combined bypass surgery and direct bypass surgery offered similar revascularization for hemorrhagic MMD. Bypass patency and dural angiogenesis both contributed to revascularization independently. The potential of indirect bypass to grow new vessels in hemorrhagic-MMD patients was generally limited, but dural leaflets offered better neoangiogenesis than STA grafts and was therefore recommended for surgical revascularization of hemorrhagic MMD.

Project description:Percutaneous radiofrequency thermocoagulation (RFT) of the Gasserian ganglion is an effective treatment for primary trigeminal neuralgia (pTN). Currently Hartel anterior approach is the most commonly used method to access the Gasserian ganglion. However, this approach is associated with high recurrence rate and technical difficulties in certain patients with foramen ovale (FO) anatomical variations. In the present study, we assessed the feasibility of accessing the Gasserian ganglion through the FO from a mandibular angle under computed tomography (CT) and neuronavigation guidance.A total of 108 patients with TN were randomly divided into 2 groups (Group G and Group H) using a random number table. In Group H, Hartel anterior approach was used to puncture the FO; whereas in Group G, a percutaneous puncture through a mandibular angle was used to reach the FO. In both groups, procedures were guided by CT imaging and neuronavigation. The success rates, therapeutic effects, complications, and recurrence rates of the 2 groups were compared.The puncture success rates in Group H and Group G were 52/54 (96.30%) and 49/54 (90.74%), respectively (P = 0.24). The 2 procedural failures in Group H were rescued by using submandibular trajectory, and the 5 failures in Group G were successfully reapproached by Hartel method. Therapeutic effects as measured by Barrow Neurological Institute (BNI) pain scale (P = 0.03) and quality of life (QOL) scores (P = 0.04) were significantly better in Group G than those in Group H at 36 months posttreatment. Hematoma developed in 1/54 (1.85%) cases in Group H, and no cases of hematoma were observed in Group G (P = 0.33). In Group H, RFT resulted in injury to the unintended trigeminal nerve branches and motor fibers in 27/52 (51.92%) cases; in Group G, it resulted in the same type of injury in 7/49 cases (14.29%) (P < 0.01). In Group H, the 24- and 36-month recurrence rates were 12/51 (23.53%) and 20/51 (39.22%), respectively; in Group G, these recurrence rates were 7/49 (12.24%) and 9/49 (16.33%, P = 0.03), respectively.CT- and neuronavigation-guided puncture from a mandibular angle through the FO into the Gasserian ganglion can be safely and effectively used to deliver RFT for the treatment of pTN. This method may represent a viable option to treat TN in addition to Hartel approach.

Project description:IntroductionAntiplatelet therapy combining aspirin and clopidogrel is considered to be a key intervention for acute ischaemic minor stroke (AIMS) and transient ischaemic attack (TIA). However, the interindividual variability in response to clopidogrel resulting from the polymorphisms in clopidogrel metabolism-related genes has greatly limited its efficacy. To date, there are no reports on individualised antiplatelet therapy for AIMS and TIA based on the genetic testing and clinical features. Therefore, we conduct this randomised controlled trial to validate the hypothesis that the individualised antiplatelet therapy selected on the basis of a combination of genetic information and clinical features would lead to better clinical outcomes compared with the standard care based only on clinical features in patients with AIMS or TIA.Methods and analysisThis trial will recruit 2382 patients with AIMS or TIA who meet eligibility criteria. Patients are randomly assigned in a 1:1 ratio to pharmacogenetic group and standard group. Both groups receive a loading dose of 300 mg aspirin and 300 mg clopidogrel on day 1, followed by 100 mg aspirin per day on days 2-365. The P2Y12 receptor antagonist is selected by the clinician according to the genetic information and clinical features for pharmacogenetic group and clinical features for the standard group on days 2-21. The primary efficacy endpoint is a new stroke event (ischaemic or haemorrhagic) that happens within 1 year. The secondary efficacy endpoint is analysed as the individual or composite outcomes of the new clinical vascular event (ischaemic stroke, haemorrhagic stroke, myocardial infarction or vascular death). Baseline characteristics and outcomes after treatment will be evaluated.Ethics and disseminationThis protocol has been approved by the ethics committee of Yangpu Hospital, Tongji University School of Medicine (No. LL-2018-KY-012). We will submit the results of this trial for publication in a peer-reviewed journal.Trial registration numberChiCTR1800019911; Pre-results.

Dataset Information

Multimodal neuronavigation-guided precision bypass in adult ischaemic patients with moyamoya disease: study protocol for a randomised controlled trial.

Publications

Multimodal neuronavigation-guided precision bypass in adult ischaemic patients with moyamoya disease: study protocol for a randomised controlled trial.

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