Neoplasms

Nervous System Diseases

All Conditions

Rare Diseases

Brain Neoplasms

Meningioma

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Dermatologic Agents

Anesthetics

Coal Tar

Therapeutic endovascular embolization in general anesthesia

Endovascular embolization

Ole Solheim, PhD

Ole Solheim, MD, PhD

The natural course for meningioma suggests that a majority will grow over time. Treatment is usually indicated in growing or symptomatic meningiomas. Surgery is usually primary treatment, but there is a significant risk of adverse effects. Stereotactic radiotherapy is most often reserved to treat relapses after surgery, and except for surgery and radiotherapy there are no other established treatment methods. Endovascular embolization may be used in selected cases as a preoperative adjunct to reduce intraoperative bleeding. There is a need for more treatment options in patients with meningioma, both in uncomplicated, asymptomatic cases and in more complex cases. The aim of this study is to assess radiological and clinical results of therapeutic endovascular embolization for meningioma

Historical controls from a regional brain tumor registry

Embolization for Meningioma

Therapeutic Endovascular Embolization for Intracranial Meningioma

Landriel Ibanez classification (grade 3 or 4 complications)

The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 questionnaire

National Institutes of Health Stroke Scale (NIHSS)

\>10 points in Karnofsky performance status

St. Olavs Hospital

Symptoms and General Pathology

Hemorrhage

Head and Neck Neoplasms

Embolisation is an effective measure to reduce intraoperative bleeding for vascular tumours of the head and neck. It is often carried out from 24 to 72 hours prior to the surgical resection to allow time for maximal thrombosis of the occluded vessels and prevent recanalisation of the occluded arteries or formation of collateral arterial channels. Data will be collected for primary and secondary outcome measures

Embolisation is an effective measure to reduce intraoperative bleeding for vascular tumours of the head and neck. It is often carried out from 24 to 72 hours prior to the surgical resection to allow time for maximal thrombosis of the occluded vessels and prevent recanalisation of the occluded arteries or formation of collateral arterial channels.

Trial Manager

Vinidh Paleri

Transoral robotic surgery (TORS )has been shown to offer excellent oncological and functional outcomes for treating cancer at multiple subsites of the head and neck. Post operative haemorrhage (3.1% to 13.1%) is the most common complication of this procedure and can lead to airway compromise. Ligation of individual feeding vessels in the neck can limit risk of severe bleed and is usually done when concomitant neck dissection is carried out with TORS. In salvage TORS, in the absence of any nodal disease of the neck, the neck is explored, nevertheless, for the sole purpose of tying the vessel. Endovascular embolisation is a minimally invasive, safe and effective procedure; known for treating refractory epistaxis and for reducing intra-operative bleeding for benign vascular head and neck tumour. The investigators propose that superselective endovascular embolisation to occlude feeding blood vessels prior to TORS in patients who do not require neck dissection is a feasible, safe and acceptable intervention; and therefore a plausible alternative conventional open neck vessel ligation.

The incidence of squamous cell carcinoma of oropharynx has increased at an alarming rate attributed to human papillomavirus (HPV).The prognosis of patients with HPV-associated oropharyngeal cancer is significantly improved, and as such, consideration of functional outcomes has become increasingly important. Transoral robotic surgery (TORS) has been shown to offer excellent oncological outcomes and low incidence of positive margins with promising functional outcome at multiple subsites of the head and neck. Like many oropharyngeal surgeries, bleeding is the most common complication after TORS. Postoperative oropharyngeal haemorrhage, particularly when severe, can lead to airway compromise, aspiration, asphyxiation, and cardiopulmonary arrest. Its incidence has been variable in literature, with rates ranging from 3.1% to 13.1%. It is an area of current interest because of the increasing adoption of TORS and the active recruitment to current multi-centre randomized controlled trials, such as ECOG 3311 (NCT01898494) and PATHOS. Ligation of the individual feeding vessels from the external carotid artery (e.g. ascending pharyngeal, lingual and facial branches) has shown to limit the risk of postoperative haemorrhage and is highly recommended. This is usually done when concomitant neck dissection is carried out with transoral resection. However, in the absence of any nodal disease, for instance in salvage TORS for recurrent oropharyngeal cancer, the neck is surgically explored for the sole purpose of tying the vessel. This is particularly more difficult surgically and carries a higher risk of failure in patients who had exposure to prior radiation where healing can be dramatically delayed. Embolisation, first described in 1974, is now a well-recognised treatment for refractory epistaxis and an effective measure to reduce intraoperative bleeding for vascular tumours of the head and neck. The latter is often carried out from 24 to 72 hours prior to the surgical resection to allow time for maximal thrombosis of the occluded vessels and prevent recanalization of the occluded arteries or formation of collateral arterial channels. This procedure has been proven to be minimally invasive, safe and effective in controlling haemorrhage even in cases of acute carotid blowout syndrome. The targeted vessels for embolisation are also branches of the external carotid artery, of similar calibre and size to the feeding vessels which are ligated in TORS. Although endovascular embolisation of branches of external carotid artery has not been carried out for the purpose of TORS in the past, it has been highly successful in controlling of bleeding in the case of benign vascular tumours of head and head. The investigators propose that this standard endovascular embolisation can also be applied to patient undergoing TORS who do not require neck dissection. The investigators believe that this is a feasible, safe and acceptable intervention and a plausible alternative to conventional open neck vessel ligation.

Non-randomised interventional feasibility study at a single institution

Haemorrhage Risk Reduction Using Endovascular Embolisation in Place of Vessel Ligation for Patients Undergoing Transoral Robotic Surgery (HELPR)

Measure by the calculating the proportion of successful completion of embolisation procedure out of the total number of patients eligible for the embolisation procedure.

Measure by the calculating the proportion of successful completion of open neck vessel ligation procedure out of the total number of patients who undergo this procedure.

Measured by calculating the proportion of major or minor adverse event sites out of all patients who undergo embolisation

Measured by calculating the proportion of post-operative bleeding from the primary site in all patients who undergo embolisation

Qualitative methods only, therefore no quantitative endpoint

Measured by calculating the proportion of major or minor adverse event sites out of all patients who undergo open neck vessel ligation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Embolization for Meningioma	NCT05416567	Meningioma	Endovascular em...	18 Years -	St. Olavs Hospital
Embolization for Meningioma	NCT05416567	Meningioma	Endovascular em...	18 Years -	St. Olavs Hospital
Haemorrhage Risk Reduction Using Endovascular Embolisation in Place of Vessel Ligation for Patients Undergoing Transoral Robotic Surgery (HELPR)	NCT05477992	Head and Neck C...	Endovascular em...	18 Years -	Royal Marsden NHS Foundation Trust
Haemorrhage Risk Reduction Using Endovascular Embolisation in Place of Vessel Ligation for Patients Undergoing Transoral Robotic Surgery (HELPR)	NCT05477992	Head and Neck C...	Endovascular em...	18 Years -	Royal Marsden NHS Foundation Trust
Embolization for Meningioma	NCT05416567	Meningioma	Endovascular em...	18 Years -	St. Olavs Hospital

Spots Global Cancer Trial Database for endovascular embolization