Gastrointestinal Motility in Patients With Neuroendocrine Tumors

Completed

• Conditions: Neuroendocrine Tumor
• Interventions: Device: Magnetic Tracking System (MTS) and radio-opaque markers

• Registration Number: NCT00789841
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-11
• Study First Submitted QC: 2008-11-12
• Study First Posted: 2008-11-13
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-25
• Last Update Posted: 2010-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with NET and diarrhea.	Magnetic Tracking System (MTS) and radio-opaque markers	-

Primary Outcome Measures

Name	Time	Method
Gastrointestinal transit time in NET patients	End of the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A; 🇩🇰 Aarhus, Denmark