Gastrointestinal Motility in Patients With Neuroendocrine Tumors

Neuroendocrine Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789841
• Other study ID #: M-20080121
• Status: Completed
• Phase: N/A
• First received: November 11, 2008
• Last updated: October 25, 2010
• Start date: September 2008
• Est. completion date: May 2010

Study information

• Verified date: October 2010
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumor
• Neuroendocrine Tumors

Intervention

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 ?, f) 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.

Locations

Country	Name	City	State
Denmark	Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Novartis, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal transit time in NET patients		End of the study	No
Secondary	Gastric emptying in NET patients		End of the study	No
Secondary	Small intestinal transit time		End of the study	No
Secondary	Small intestinal velocity		End of the study	No
Secondary	Changes in carcinoid symptoms and biomarkers		End of the study	No