Head and Neck

Lead: Dr. Roganie Govender

SIP SMART2 is a multi-centre pilot cluster-randomised trial of a tailored swallowing prehabilitation intervention for people newly diagnosed with head and neck cancer. The main aims are:

1) Assess the feasibility and acceptability of the intervention to those receiving and delivering SIP SMART

2) Identify any process and implementation issues related to delivery

3) Determine whether it meets the apriori criteria to proceed to a larger definitive trial.

• Start Date: 03 Aug 2022
• End Date: 30 Sep 2023   
• Current Status: Closed to recuirtment, in follow-up

Lead: Professor Mark McGurk, Dr Vin Patel

An open invitation multidisciplinary UK collaborative project to discuss and shape current management of odontogenic tumours.  Odontogenic tumours are extremely rare meaning sharing knowledge and experience is key to improving outcomes. Recent studies suggest drug treatment, such as BRAF-inhibitors, can reduce the morbidity of conventional surgical treatment. This forum aims to provide practical expert advice as well as supporting access to novel therapies through clinical trials

• Start Date: 06 Mar 2024
• End Date: TBC   
• Current Status: Data Collection

Lead: Mr Nicholas Hamilton

A UK multidisciplinary collaborative project to evaluate the outcomes of tracheostomy in COVID-19 patients. It also examines the implementation of national guidance in COVID-19 tracheostomies and the incidence of COVID-19 infections amongst those health care workers involved in the procedure. 

COVIDTrach Clinical Trial Protocol

• Start Date: 01 Apr 2020
• End Date: 30 Sep 2021    
• Current Status: BMJ Publication / PDF

Background

When COVID-19 leads to a severe infection in the lung, patients need to be placed on a ventilator. Before the pandemic, clinical practice was for patients expected to be on a ventilator for over 7 days to undergo a tracheostomy, a surgical procedure to put a breathing tube through the neck into the airway.

It is uncertain whether patients with COVID-19 also benefit from this operation due to the severity of their respiratory illness and high death rate. Furthermore, there is concern that opening the airway through the tracheostomy puts health care professionals performing the procedure at risk of being infected by the coronavirus.

COVIDTrach is collaborative project by surgeons and intensive care doctors that looks at the outcomes of ventilated COVID-19 patients undergoing tracheostomy and evaluates the use of personal protective equipment and rate of COVID-19 infection amongst operators.

So far, data on 800 patients have been entered in an online database; this proposal focuses on expanding and completing this database to answer the fundamental questions of the safety and effectiveness of tracheostomy in COVID-19.

Sponsors

• UCL Rapid Response COVID-19 Fund / Wellcome Trust
• NIHR Clincal Research Network
• The Federation of Surgical Specialty Associations
• Intensive Care Society
• Difficult Airway Society

Contributors (By site)

• Aberdeen Royal Infirmary
• Addebrooke's Hospital
• Aintree Univeristy Hospitals NHS Trust
• Ashford St Peter's
• Barking, Havering and Redbridge NHS Trust
• Barnet Hospital
• Basingstoke & North Hampshire Hospital
• Bedford Hospitals NHS Foundation Trust
• Birmingham Queen Elizabeth Hospital
• Birmingham City Hospital
• Birmingham Heartlands & Goodhope Hospital
• Bodelwyddan - Glan Clwyd Hospital
• Bradford Royal Infirmary
• Bristol Royal Infirmary
• Broomfield Hospital
• Chelsea & Westminister
• Colchester Hospital
• Conquest Hospital
• Countess of Cheester Hospital
• Coventry and Warwickshire Hospital
• Croydon Hospital
• Doncaster Royal Hospital
• Dumfries and Galloway
• East Surrey Hospital    
• Eastbourne District General Hospital
• Forth Valley Royal Hospital
• Glasgow Royal Infirmary
• Gloucestershire Hospitals NHS Trust
• Great Western Hospital
• GSTT
• Harefield Hospital
• Hereford Country Hospital
• Hillingdon Hospital
• Homerton University Hospital
• Imperial NHS Trust
• Inverclyde Royal Infirmary
• Isle of Wight
• James Paget Hospital
• John Radcliffe

• Kent and Centerbury
• King's College Hospital
• Kings Mill Hospitall
• Leeds General Infirmary
• Leicester Royal Infirmary
• Lewisham Hospital
• Lister Hospital
• Maidstone and Turnbridge Wells NHS Trust
• Manchester University Foundation Trust
• Medway Maritime Hospital
• Monklands General Hospital
• Morriston
• Musgrove Park Hospital
• Nevill Hall Hospital
• New Cross Hospital
• Newcastle Hospital
• Norfolk and Norwich University Hospital
• North Cumbria Integrated Care
• Northumbria Healthcare NHS Trust
• Northwick Park Hospital
• Peterborough City Hospital
• Pinderfields Hospital
• Prince Charles Hospital Merthyr Tydfil
• Princess Alexandra Hospital
• Queens Alexandra Hospital
• Queen Elizabeth Univeristy Hospital
• Queens Medical Centre
• Queen's Hospital (Burton)
• Raigmore Hospital, Inverness
• Royal Albert Edward Hospital
• Royal Alexandra Hospital
• Royal Berkshire NHS Foundation Trust
• Royal Blackburn Hospital
• Royal Bolton Hospital
• Royal Cornwall Hospital
• Royal Derby Hospital
• Royal Free Hospital
• Royal Gwent Hospital
• Royal Liverpool Hospital

• Royal London Hospital (Barts Health)
• Royal Preston Hospital
• Royal Sussex County Hospital
• Russells Hall
• Sailsbury District Hospital
• Scarborough Hospital
• Sheffield Teaching Hospital
• Shrewsbury and Telford Hospitals
• Southend Univeristy Hospital
• St Georges Hospital
• St Helens & Knowsley Teaching Hospitals NHS Trust
• St John's Hospital at Howden
• Stepping Hill Hospital
• Stoke Mandeville Hospital    
• Sunderland Royal Hospital
• Tameside & Glossop Integrated Care NHS Trust
• The James Cook University Hospital
• The Rotherham NHS Foundation Trust
• The Whittington Hospital
• Tunbridge Wells Hospital
• University College London Hospitals
• University Hospital of North Midlands
• University Hospital of Wales
• University Hospital Southampton
• University Hospitals Bristol and Weston NHS Foundation Trust
• University Hospitals Derby & Burton
• University Hospitals Plymouth
• Walsall Manor Hospital
• Watford General Hospital
• West Middlesex Hospital
• West Suffolk Hospital
• Wexham Park Hospital
• Whipps Cross Univeristy Hospital (Barts Health)
• Whittington Hospital
• William Harvey Hospital
• Wrexham Maelor Hospital
• Wythenshawr Hospital
• York Hospital

Publications

Preprint report: COVIDTrach collaborative, NJI Hamilton, et al., COVIDTrach; a prospective cohort study of mechanically ventilated COVID-19 patients undergoing tracheostomy in the UK. (2020). medRxiv 2020.10.20.20216085.

Interim Report: COVIDTrach; the outcomes of mechanically ventilated COVID-19 patients undergoing tracheostomy in the UK. (2020). BJS. 107 (12), e583-e584.

A multi-centre validation study to evaluate whether a new imaging and surgical protocol would work as well as the current god standard in identifying sentinel nodes in patients with oropharyngeal cancer. This study aims to give doctors more accurate information on which side(s) of the neck to treat following the discovery of cancer in the lymph glands.

LOOC Clinical Trial Protocol

• Start Date: 01 Sept 2020
• End Date: 31 July 2024    
• Current Status: Recruitment

Background

Cancer at the back of the mouth and throat is usually only discovered after it has spread to lymph glands in the neck. This means that both the original tumour and the cancer that has spread needs to be treated.

Doctors need to decide whether to treat just one side of the neck or to treat both, as the cancer may have spread to both sides or may be likely to spread to another side in the future. They base this decision on things such as how aggressive the cancer is, whether the patient smokes and whether the HPV virus is present. This difficult decision can mean some patients get treatment on both sides of the neck that they may not need, which can result in lasting problems with swallowing. Others can receive treatment on one side only to have the cancer return on the other.

This study hopes to give doctors more accurate information on whether to treat one side or two. This will be done using a procedure called Sentinel Node Biopsy (SNB) to see whether the cancer has spread to the other side of the neck. 

The first part of the study is the imaging part, where a radioactive substance called ‘Lymphoseek’ will be injected into the tumour. This substance quickly moves into the lymph nodes and those to which it moves first are the sentinel nodes. A handheld detector called a gamma camera can be used to detect where these are. As part of standard care patients are examined under anaesthesia (EUA) and when this happens patients in the study will have Lymphoseek injected into these sentinel nodes. To make sure the gamma camera has identified the correct nodes the patients will have a CT scan the next day.

The second part of the study is the surgery part. This will involve a new group of patients who will have the same imaging procedure. Those patents with sentinel nodes in the other side of the neck will have them removed during the EUA and these nodes will be examined for signs of cancer. Some patients in this part, with easily accessible tumours, will have their tumour injected with Lymphoseek under local anaesthetic a few days after their original injection. If this is acceptable to patients, it may reduce the number of visits and general anaesthetics they receive.

If this study is successful, we will have found a way to give doctors much better, more accurate information on what treatment to give and speed up the time that it takes for patients to go through the treatment process.

Sponsors

• UCL
• NIHR Clinical Research Network

There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery. Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care. CovidSurg has been designed by an international collaborating group of surgeons and anaesthetists which has now reached 69 countries.

CovidSurg Clinical Trial Protocol

• Start Date: 14 July 2020
• End Date: 14 July 2025    
• Current Status: Data Collection

Criteria

Patients must meet the following two criteria:

• Undergoing any type of surgery in an operating theatre, including obstetrics.
• Either before or after surgery: (i) lab test confirmed SARS-CoV2 infection or (ii) clinical diagnosis of COVID-19 (no test performed).

Any hospital can participate. Some hospitals might currently have few cases while others might have a lot. Every hospital treating or expecting to treat surgical patients with COVID-19 infection is welcome.

The primary outcome is mortality at 30 days after surgery. Secondary outcomes will be other surgical and medical complications.

There is no fixed data collection period and patients can be included either prospectively or retrospectively.

Data will be stored in a secure online platform (REDCap). Only anonymised data will be collected.

All the collaborators will be recognised as co-authors in any publications resulting from this study. A corporate authorship model will be used under CovidSurg Collaborative group.

Sponsors

• NIHR Global Health Research Unit