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

July 26, 2022 updated by: Royal Marsden NHS Foundation Trust
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For Main Study:

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Inclusion Criteria

  • 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

Exclusion Criteria

- Patients known to have undergone previous ligation or embolisation of the ipsilateral external carotid artery or the relevant feeding branches.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endovascular embolisation
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of embolisation procedure
Time Frame: Day 1 post the 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
Time Frame: Day 1 post 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of embolisation procedure
Time Frame: Day 30 post embolisation procedure
Measured by calculating the proportion of major or minor adverse event sites out of all patients who undergo embolisation
Day 30 post embolisation procedure
Efficacy of embolisation procedure
Time Frame: Day 30 post embolisation procedure
Measured by calculating the proportion of post-operative bleeding from the primary site in all patients who undergo embolisation
Day 30 post embolisation procedure
Acceptability of embolisation procedure
Time Frame: After day 30 post procedure, at the time of focus group discussion
Qualitative methods only, therefore no quantitative endpoint
After day 30 post procedure, at the time of focus group discussion
Safety of open neck vessel ligation
Time Frame: Day 30 post open neck vessel ligation
Measured by calculating the proportion of major or minor adverse event sites out of all patients who undergo open neck vessel ligation
Day 30 post open neck vessel ligation
Efficacy of open neck vessel ligation
Time Frame: Day 30 post open neck vessel ligation
Measured by calculating the proportion of major or minor adverse event sites out of all patients who undergo open neck vessel ligation
Day 30 post open neck vessel ligation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Vinidh Paleri, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR5262

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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