Gastrointestinal Motility in Patients With Neuroendocrine Tumors
NCT ID: NCT00789841
Last Updated: 2010-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
13 participants
OBSERVATIONAL
2008-09-30
2010-05-31
Brief Summary
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Hypothesis: Patients with NET and carcinoid syndrome have decreased GITT, gastric emptying and small bowel transit time and an increase in phase III MMC activity compared to healthy subjects. Treatment with somatostatin analogues increase transit times and decrease phase III MMC activity and improves the clinical symptoms.
Detailed Description
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Conditions
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Study Groups
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Patients with NET and diarrhea.
Magnetic Tracking System (MTS) and radio-opaque markers
MTS: A small magnetic pill (6x15mm) is swallowed by the patient and the movement of this pill is registered by a sensor (coordinates x,y,z angles θ, φ) and depicted af graphs on a computer screen. For determination of GITT a capsule containing 10 radio-opaque markers is ingested every day for six days, on day seven an abdominal x-ray is performed.
Interventions
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Magnetic Tracking System (MTS) and radio-opaque markers
MTS: A small magnetic pill (6x15mm) is swallowed by the patient and the movement of this pill is registered by a sensor (coordinates x,y,z angles θ, φ) and depicted af graphs on a computer screen. For determination of GITT a capsule containing 10 radio-opaque markers is ingested every day for six days, on day seven an abdominal x-ray is performed.
Eligibility Criteria
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Inclusion Criteria
* Diarrhea, (at least 3 loose or watery bowel movements per day) as part of carcinoid syndrome.
* Newly referred patients without previous somatostatin analogue treatment or
* NET patients who are pausing somatostatin analogue treatment due to other treatment or examination.
Exclusion Criteria
* Severe diabetes with late complications or known metabolic disorder
* Inflammatory bowel disease
* Known clinically significant stenosis of the bowel
* Bile acid malabsorption due to intestinal surgery
* Small bowl bacterial overgrowth
30 Years
80 Years
ALL
Yes
Sponsors
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Novartis
INDUSTRY
The Danish Medical Research Council
OTHER
University of Aarhus
OTHER
Responsible Party
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Medical Department V, Aarhus University Hospital
Locations
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Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A
Aarhus, Aarhus, Denmark
Countries
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Other Identifiers
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M-20080121
Identifier Type: -
Identifier Source: org_study_id