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Antro-pyloro-duodenal Motility in Idiopathic Gastroparesis

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition
Gastroparesis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of the Antro-pyloro-duodenal Motor Dysfunction in Idiopathic Gastroparesis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control group
Healthy volunteers
Idiopathic gastroparesis
Idiopathic gastroparesis

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Idiopathic gastroparesis and healthy volunteers

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519180

Locations
France
Service de Physiologie Recruiting
Rouen, Haute normandie, France, 76000
Contact: Guillaume Gourcerol, MD, PhD     0232888990 ext 68039     guillaume.gourcerol@chu-rouen.fr    
Principal Investigator: Guillaume Gourcerol, MD, PhD            
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Guillaume Gourcerol, MD, PhD Chu de rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01519180     History of Changes
Other Study ID Numbers: 2010/148/HP
Study First Received: January 18, 2012
Last Updated: February 5, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
gastroparesis
gastric emptying
antro-duodenal manometry

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013