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OpenTrials
Completed

NCT Number: NCT00789841

Gastrointestinal Motility in Patients With Neuroendocrine Tumors

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.

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Key information

Conditions

Neuroendocrine Tumor Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Serotonin Syndrome

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Tracking System (MTS) and radio-opaque markers

Device

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.

Primary outcomes

  1. Gastrointestinal transit time in NET patients

    Time frame: End of the study

Secondary outcomes

  1. Gastric emptying in NET patients

    Time frame: End of the study

  2. Small intestinal transit time

    Time frame: End of the study

  3. Small intestinal velocity

    Time frame: End of the study

  4. Changes in carcinoid symptoms and biomarkers

    Time frame: End of the study

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Novartis
  • The Danish Medical Research Council

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 13, 2008
Registry last updated
Oct 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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