FLOTOR Trial

  • Research type

    Research Study

  • Full title

    FLuOrescence to highlight Thoracic Duct during Oesophageal Resections

  • IRAS ID

    229559

  • Contact name

    Richard Gillies

  • Contact email

    flotortrial@ouh.nhs.uk

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    The lymphatic system is a network of channels and glands which drain fluid (lymph) from areas of the body back into the blood circulation. One of the major lymphatic channels, the thoracic duct, transports lymph fluid and fats (also known as chyle) from most of the body into one of the main veins. It is located in the chest cavity very close to the gullet (oesophagus). It is around 5mm in diameter.

    For oesophageal cancer, the operative management involves removal of the oesophagus (oesophagectomy). The thoracic is often difficult to see during surgery, placing it at high risk of injury. If injured, the contents (chyle) of the thoracic duct can leak out into the chest and surround the lungs. This prolongs the length of stay in hospital and is associated with a death rate of up to 30%.

    There are ways in which the thoracic duct has attempted to been seen by using cream ingestion, or special dyes. A modern way of imaging lymphatic channels and glands is to use invisible light (near infra-red (NIR) imaging) that is emitted from certain types of dyes. The most commonly used NIR dye is called indocyanine green (ICG) which is widely used to visualise the lymphatic system in other parts of the body.

    The aim of this study is to assess the use of ICG to highlight the thoracic duct during oesophagectomy. It is a single site, unblinded, non-randomised single intervention study. Two methods of ICG administration during surgery will be assessed: ICG and cream via the feeding tube made during the operation and; ICG injection into the small bowel drainage system. Using an NIR enabled camera the thoracic duct will attempt to be visualised. The intervention and assessment occur on the day of surgery.

  • REC name

    Wales REC 7

  • REC reference

    17/WA/0295

  • Date of REC Opinion

    28 Sep 2017

  • REC opinion

    Favourable Opinion