Esophageal Cancer Clinical Trial
Official title:
FLuOrescence to Identify the Thoracic Duct During Oesophageal Resections
This is a non-randomised study assessing the technique of using indocyanine green as a fluorescent dye to highlight the thoracic duct during oesophectomy.
The thoracic duct is the largest vessel of the lymphatic system in the body. It transports
chyle (a liquid containing both lymph and emulsified fats) from most of the body, including
the gastrointestinal tract, into the left internal jugular vein. It is largely located in the
thorax and is at risk of injury during the thoracic part of an oesophagectomy.
The reported incidence of thoracic duct injury during oesophagectomy is between 0.2 and
10.5%, although it may be under-reported in the literature. A review of prospective collected
complication data from 292 consecutive oesophagectomies performed in Oxford over a 5 year
period revealed a chyle leak rate of 9.9%. Chyle leak was associated in a doubling of median
length of post-operative stay from 8 to 16 days in these patients. Chylothorax has been
associated with a mortality of up to 30%.
Over the years, a number of attempts have been made to visualise chyle leakage following
thoracic duct injury including administration of enteral fat containing feed (e.g. double
cream), methylene blue and lymphoscintigraphy, but no studies have been published showing a
mechanism to aid thoracic duct identification at the index operation, and so prevent
injuries.
Fluorescence is a technique which uses fluorescent dyes (fluorophores) that emit invisible
(near infra-red (NIR)) light when they are excited by light at a particular wavelength. In
order to use this technique, a fluorescence-enabled camera is required in order to shine
light at that particular wavelength on the fluorophore and to capture the light emitted. This
is then displayed on a screen for the surgeon to see.
Indocyanine green (ICG) is a fluorescent molecule that is approved by the FDA (Food and Drug
Administration) and the MHRA for use in humans. It is a widely used near infra-red dye for
numerous operations. Near infra-red guided lymphatic mapping with ICG has gained much
attention over recent years and its use has widely been published in breast and colorectal
surgery. ICG has also been successfully used to identify the thoracic duct in a number of
case reports in both adults and children.
ICG can be injected into the small bowel mesentery to aid identification of thoracic duct
injury at re-exploration. This study aims to assess the feasibility of using ICG fluorescence
to identify the thoracic duct during oesophagectomy, with the eventual aim of developing its
routine use to prevent thoracic duct injuries.
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