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Gastrointestinal Motility in Patients With Neuroendocrine Tumors

This study has been completed.
The Danish Medical Research Council
Information provided by:
University of Aarhus Identifier:
First received: November 11, 2008
Last updated: October 25, 2010
Last verified: October 2010

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 Intervention
Neuroendocrine Tumor
Device: Magnetic Tracking System (MTS) and radio-opaque markers

Study Type: Observational
Official Title: Gastrointestinal Motility in Patients With Neuroendocrine Tumors-Effects of Sandostatin LAR

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

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

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

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

Enrollment: 13
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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.

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
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Please refer to this study by its identifier: NCT00789841

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

Responsible Party: Henning Grønbæk, M.D., Ph.D., Medical Department V, Aarhus University Hospital Identifier: NCT00789841     History of Changes
Other Study ID Numbers: M-20080121
Study First Received: November 11, 2008
Last Updated: October 25, 2010

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

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial processed this record on May 25, 2017