Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00212420 |
| Other study ID # |
04/Q0405/CEF106 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
September 13, 2005 |
| Last updated |
September 21, 2007 |
| Start date |
December 2004 |
Study information
| Verified date |
September 2007 |
| Source |
London North West Healthcare NHS Trust |
| Contact |
David AJ Lloyd, MA, MRCP |
| Email |
david.lloyd[@]nwlh.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
United Kingdom: National Health Service |
| Study type |
Interventional
|
Clinical Trial Summary
To Investigate whether different routes of nutrition affect the probability of fistula
closure in patients with an enterocutaneous fistula
Description:
Enterocutaneous fistulae are abnormal connections between bowel and skin through which bowel
contents pass. Their management present a considerable medical and surgical challenge. Since
the 1970s the mainstray of treatment has been supportive with initiation of a "nil by mouth"
regimen and intravenous (parenteral) nutrition with the aim of stabilising the patient and
inducing gastrointestinal tract rest. There seems to have been an unquestioned benefit
attributed to total parenteral nutrition (TPN) in the 1970s and 1980s which has carried
through to the current day. This rigid approach to the management of enterocutaneous
fistulae is almost universal and yet an extensive literature search suggests both mixed
results from clinical trials and mixed opinions from experts in the field.
A large study published in the late 1970s (Souters et al. 1979) demonstrated that there was
a 44% mortality in patients with an enterocutaneous fistula from 1946 to 1959 which fell to
15% between 1960 and 1970 with the introduction of improved parasurgical care; after 1970 no
further decrease in mortality rate was observed despite the introduction of parenteral
nutrition. It could therefore be argued that parenteral nutrition offers no real additional
benefit to these patients. Surprisingly there is no information in the literature comparing
enteral nutrition with parenteral nutrition in patients with an enterocutaneous fistula.
Enter nutrition is more physiological, is associated with fewer complications and is cheaper
when compared to parenteral nutrition. If parenteral nutrition were shown to offer no
benefit with regards to fistula closure in patients with enterocutaneous fistula then
enteral feeding would be the nutritional modality of choice. This would constitute a major
shift in the current management of such patients.
Recent research has shown that the supply of nutrients to the lining of the gastrointestinal
tract can have a significant effect on the growth of the cells lining the gut and on the
motility as a whole. Many of these effects are mediated by intestinal growth factors such
and glucagon-like peptide-2 (GLP-2) and gut hormones such as cholecystokinin (CCK) and
peptide YY (YYY. Although no studies have been performed looking at the levels of growth
factors and gut hormones in patients with enterocutaneous fistulae, it seems theoretically
likely that the route of nutrition in these patients will have an effect on the levels of
these intestinal growth factors and gut hormones. This in turn may have effect on fistula
healing and fistula output. Modulation of the levels of these growth factors and gut
hormones may provide new therapeutic options in the future management of enterocutaneous
fistulae.
