Gastrointestinal Motility in Patients With Neuroendocrine Tumors

Study Overview
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Brief Summary
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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.

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

Conditions
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Neuroendocrine Tumor

Intervention / Treatment
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* Device: Magnetic Tracking System (MTS) and radio-opaque markers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with NET and diarrhea.<br> | Device: Magnetic Tracking System (MTS) and radio-opaque markers<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal transit time in NET patients |  | End of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuroendocrine tumor, Carcinoid syndrome, Motility, Transit time