The HELPR Study
Research type
Research Study
Full title
Haemorrhage risk reduction using endovascular Embolisation in place of vessel Ligation for Patients undergoing transoral Robotic surgery
IRAS ID
279065
Contact name
Vinidh Paleri
Contact email
Sponsor organisation
Royal Marsden Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
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. We 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.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0186
Date of REC Opinion
7 Jul 2022
REC opinion
Further Information Favourable Opinion