Status not kept up to date
Haemorrhage Risk Reduction Using Endovascular Embolisation in Place of Vessel Ligation for Patients Undergoing Transoral Robotic Surgery (HELPR)
NCT05477992 · Royal Marsden NHS Foundation Trust · Updated 28 July 2022
- What is being tested
- Endovascular embolization
- For
- Head and Neck Cancer
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 10 people. The full rules are on the registry page.
- Where
- Not stated
- When
- Starts or started 1 Aug 2022, ends Nov 2023. Registered 28 July 2022.
- Results
- None posted yet.
In the researchers' words
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.
