Antro-pyloro-duodenal Motility in Idiopathic Gastroparesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01519180
First received: January 18, 2012
Last updated: February 5, 2013
Last verified: February 2013

January 18, 2012
February 5, 2013
January 2012
January 2014   (final data collection date for primary outcome measure)
antro-pyloro-duodenal pressure [ Time Frame: 3h ] [ Designated as safety issue: No ]
the main outcome is the pressure measured using pressure sensors within the antrum, the pylorus, and the first part of the duodenum. This will be measured during 3h fast. Pressures measured in the antrum, the pylorus, and the duodenum wiil be compared between healthy volunteers and gastroparetic patients
Same as current
Complete list of historical versions of study NCT01519180 on ClinicalTrials.gov Archive Site
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Antro-pyloro-duodenal Motility in Idiopathic Gastroparesis
Study of the Antro-pyloro-duodenal Motor Dysfunction in Idiopathic Gastroparesis

Impaired gastric emptying may cause dyspeptic symptoms including nausea, vomiting and even nutritionnal impairment. Delay in gastric emptying may result from antro-pyloro-duodenal motility impairement.

The aim of this study is therefore to measure antro-pyloro-duodenal motor activity in patients with idiopathic gastroparesis.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Idiopathic gastroparesis and healthy volunteers

Gastroparesis
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  • Control group
    Healthy volunteers
  • Idiopathic gastroparesis
    Idiopathic gastroparesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Idiopathic gastroparesis or healthy volunteers
  • Idiopathic gastroparesis must have delayed gastric emptying shown using C13 breath test

Exclusion Criteria:

  • Diabetic or post-surgical gastroparesis
  • Treatment modifying GI motility (prokinetics, opioids...)
  • Parkinson or neurologic disease
  • Evoluting inflammatory process or neoplasia
  • Treatment modifying coagulation
  • Patients not affiliated to the French healthcare insurance
Both
18 Years to 75 Years
Yes
France
 
NCT01519180
2010/148/HP
Yes
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Guillaume Gourcerol, MD, PhD Chu de rouen
University Hospital, Rouen
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP