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Clinical Trials/NCT00789841
NCT00789841
Completed
Not Applicable

Gastrointestinal Motility in Patients With Neuroendocrine Tumors-Effects of Sandostatin LAR

University of Aarhus1 site in 1 country13 target enrollmentSeptember 2008
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ConditionsNeuroendocrine Tumor

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuroendocrine Tumor
Sponsor
University of Aarhus
Enrollment
13
Locations
1
Primary Endpoint
Gastrointestinal transit time in NET patients
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
May 2010
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Gastrointestinal transit time in NET patients

Time Frame: End of the study

Secondary Outcomes

  • Gastric emptying in NET patients(End of the study)
  • Small intestinal transit time(End of the study)
  • Small intestinal velocity(End of the study)
  • Changes in carcinoid symptoms and biomarkers(End of the study)

Study Sites (1)

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