- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00212420
Nutritional Management of Acute and Chronic Enterocutaneous Fistulae
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David AJ Lloyd, MA, MRCP
- Email: david.lloyd@nwlh.nhs.uk
Study Contact Backup
- Name: Simon Gabe, MD
- Email: simon.gabe@nwlh.nhs.uk
Study Locations
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Middlesex
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Harrow, Middlesex, United Kingdom, HA1 3UJ
- Recruiting
- St Mark's Hospital, North West London Hospitals NHS Trust
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Contact:
- Alan Warnes, PhD
- Email: alan.warnes@nwlh.nhs.uk
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Contact:
- Iva Hauptmannova, MA
- Email: iva.hauptmannova@nwlh.nhs.uk
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Principal Investigator:
- David AJ Lloyd, MA MRCP
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with an enterocutaneous fistula for > 14 days who have been referred to the Nutrition Team (or Pharmacy) for initiation of parenteral nutrition
Exclusion Criteria:
- generalised peritonitis or systemic sepsis (SIRS)
- immediate need for surgery or radiological drainage procedures
- other contraindicators to either enteral or parenteral feeding
- age < 18 years old
- lack of informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To investigate whether different routes of nutrition affect the probability of fistula closure in patients with an enterocutanous fistula
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Secondary Outcome Measures
Outcome Measure |
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investigating if different routes of nutrition affect fistula output, complication rates, overall nutrition and quality of life in patients with an enterocutaneous fistula. To measure the levels of intestinal growth factors and gut hormones in patients
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David AJ Lloyd, MA, MRCP, St Mark's Hospital, North West London NHS Trust
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04/Q0405/CEF106
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.
Clinical Trials on Enterocutaneous Fistulae
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Denver Health and Hospital Authority3MWithdrawnFistulaeUnited States
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Instituto de Investigación Hospital Universitario...UnknownEnterocutaneous FistulaSpain
-
Jinling Hospital, ChinaCompletedIntra-abdominal Infection | Enterocutaneous FistulasChina
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Daniel Dante YehTakedaCompleted
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Jianan RenCompletedEnterocutaneous Fistulas
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IpsenCompletedDigestive FistulaeFrance, Russian Federation
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Ohio State UniversitySpiration, Inc.WithdrawnManagement of BPF (Bronchopleural Fistulae)United States
-
Wake Forest University Health SciencesCompleted
-
DatabeanThe Insides CompanyRecruitingIleostomy - Stoma | Intestinal Failure | Enterocutaneous FistulaUnited Kingdom, United States
Clinical Trials on parenteral nutrition; enteral nutrition
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Lawson Health Research InstituteUnknownMalignant Hematologic NeoplasmCanada
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University Hospital, LilleMinistry of Health, FranceTerminatedGastrointestinal Fistula | Enteral Nutritional SupportFrance
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Tokyo UniversityCompletedDeglutition Disorders
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University Hospital, GenevaCompleted
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Centre Hospitalier Departemental VendeeInstitut National de la Santé Et de la Recherche Médicale, France; Ministry... and other collaboratorsTerminatedShock | Acute Respiratory FailureFrance
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Centre Hospitalier Departemental VendeeInstitut National de la Santé Et de la Recherche Médicale, France; Ministry... and other collaboratorsTerminatedShock | Acute Respiratory FailureFrance
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Centre Hospitalier Departemental VendeeInstitut National de la Santé Et de la Recherche Médicale, France; Ministry... and other collaboratorsTerminatedShock | Acute Respiratory FailureFrance
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Xian-Jun YuNot yet recruitingEnteral NutritionChina
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Southeast University, ChinaCompletedSevere Burn | Enternal Nutrition