Gastrointestinal Motility in Patients With Neuroendocrine Tumors

University of Aarhus13 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neuroendocrine Tumor

Interventions

Magnetic Tracking System (MTS) and radio-opaque markersDEVICE

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

Sex: ALLMin age: 30 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A

Aarhus, Aarhus, Denmark

Outcomes

Primary Outcomes

Gastrointestinal transit time in NET patients

Time frame: End of the study

Secondary Outcomes

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

Data from ClinicalTrials.gov

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