Antro-pyloro-duodenal Motility in Idiopathic Gastroparesis

Gastroparesis Clinical Trial

Official title:

Study of the Antro-pyloro-duodenal Motor Dysfunction in Idiopathic Gastroparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519180
• Other study ID #: 2010/148/HP
• Status: Completed
• Phase: N/A
• First received: January 18, 2012
• Last updated: September 5, 2014
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroparesis

Locations

Country	Name	City	State
France	Service de Physiologie	Rouen	Haute normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antro-pyloro-duodenal pressure	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	3h	No