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

NCT05477992 | Unknown DMC

• 1 other identifier: CCR5262
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• Feasibility of embolisation procedure

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

  Day 1 post the embolisation procedure

• Feasibility of open neck vessel ligation

  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.

  Day 1 post open neck vessel ligation

Secondary Outcomes (5)

• Safety of embolisation procedure

  Day 30 post embolisation procedure

• Efficacy of embolisation procedure

  Day 30 post embolisation procedure

• Acceptability of embolisation procedure

  After day 30 post procedure, at the time of focus group discussion

• Safety of open neck vessel ligation

  Day 30 post open neck vessel ligation

• Efficacy of open neck vessel ligation

  Day 30 post open neck vessel ligation

Study Arms (1)

Endovascular embolisation

EXPERIMENTAL

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

Procedure: Endovascular embolization

Interventions

Endovascular embolization PROCEDURE

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.

Endovascular embolisation

Eligibility Criteria

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

You may qualify if:

• Residual, recurrent or new primary oropharyngeal, laryngeal or hypopharyngeal cancer, in a previously irradiated field.
• Listed for TORS resection
• Who would normally be indicated for concurrent ligation of branches of their external carotid artery for peri-operative haemorrhage control

You may not qualify if:

• Patients requiring concurrent ipsilateral neck surgery alongside their TORS resection, who would be more suited to undergo surgical vessel ligation.
• Patients known to have undergone previous ligation or embolisation of the ipsilateral external carotid artery or the relevant feeding branches.
• Females who are pregnant
• Females of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test
• Females must not be breastfeeding.
• For Retrospective Sub-Study
• Residual, recurrent or new primary oropharyngeal, laryngeal or hypopharyngeal cancer, in a previously irradiated field
• Who underwent TORS resection to manage this disease
• Who had concurrent neck surgery for surgical ligation of branches of their external carotid artery for peri-operative haemorrhage control
• \- Patients known to have undergone previous ligation or embolisation of the ipsilateral external carotid artery or the relevant feeding branches.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Related Publications (27)

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MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Vinidh Paleri

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trial Manager

CONTACT

02073528171; helpr.study@rmh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomised interventional feasibility study at a single institution

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 28, 2022
• Study Start: August 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07