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Gastrointestinal Motility in Patients With Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT00789841
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : October 26, 2010
Sponsor:
Collaborators:
Novartis
The Danish Medical Research Council
Information provided by:
University of Aarhus

Brief Summary:

We will study the total gastrointestinal transit time (GITT), gastric emptying and small intestine motility in NET patients before and after treated with somatostatin analogues and compare these to healthy subjects. For this we will use radio-opaque markers and the newly developed Motility Tracking System (MTS).

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.


Condition or disease Intervention/treatment
Neuroendocrine Tumor Device: Magnetic Tracking System (MTS) and radio-opaque markers

Study Type : Observational
Actual Enrollment : 13 participants
Official Title: Gastrointestinal Motility in Patients With Neuroendocrine Tumors-Effects of Sandostatin LAR
Study Start Date : September 2008
Primary Completion Date : May 2010
Study Completion Date : May 2010


Group/Cohort Intervention/treatment
Patients with NET and diarrhea. Device: 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.



Primary Outcome Measures :
  1. Gastrointestinal transit time in NET patients [ Time Frame: End of the study ]

Secondary Outcome Measures :
  1. Gastric emptying in NET patients [ Time Frame: End of the study ]
  2. Small intestinal transit time [ Time Frame: End of the study ]
  3. Small intestinal velocity [ Time Frame: End of the study ]
  4. Changes in carcinoid symptoms and biomarkers [ Time Frame: End of the study ]

Biospecimen Retention:   Samples With DNA
Blood samples wich are destroyed after analysis


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We are scheduling 12 subjects (30-80 years of age) with NET and carcinoid syndrome with diarrhea. Patients are recruited through the Department of Medicine V, Aarhus University Hospital.
Criteria

Inclusion Criteria:

  • NET confirmed by histology
  • 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:

  • Subjects unable to understand the information
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789841


Locations
Denmark
Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Novartis
The Danish Medical Research Council

Responsible Party: Henning Grønbæk, M.D., Ph.D., Medical Department V, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00789841     History of Changes
Other Study ID Numbers: M-20080121
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: October 2010

Keywords provided by University of Aarhus:
Neuroendocrine tumor
Carcinoid syndrome
Motility
Transit time

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue