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Gastrointestinal Motility in Patients With Neuroendocrine Tumors

This study has been completed.
Sponsor:
Collaborators:
Novartis
The Danish Medical Research Council
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00789841
First received: November 11, 2008
Last updated: October 25, 2010
Last verified: October 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Gastrointestinal transit time in NET patients [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gastric emptying in NET patients [ Time Frame: End of the study ] [ Designated as safety issue: No ]
  • Small intestinal transit time [ Time Frame: End of the study ] [ Designated as safety issue: No ]
  • Small intestinal velocity [ Time Frame: End of the study ] [ Designated as safety issue: No ]
  • Changes in carcinoid symptoms and biomarkers [ Time Frame: End of the study ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 11, 2008
Last Updated: October 25, 2010
Health Authority: Denmark: National Board of Health

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

ClinicalTrials.gov processed this record on May 19, 2013