Antro-pyloro-duodenal Motility in Idiopathic Gastroparesis

September 5, 2014 updated by: University Hospital, Rouen

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Haute normandie
      • Rouen, Haute normandie, France, 76000
        • Service de Physiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Idiopathic gastroparesis and healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group
Healthy volunteers
Idiopathic gastroparesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antro-pyloro-duodenal pressure
Time Frame: 3h
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Guillaume Gourcerol, MD, PhD, CHU de ROUEN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimate)

January 26, 2012

Study Record Updates

Last Update Posted (Estimate)

September 8, 2014

Last Update Submitted That Met QC Criteria

September 5, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/148/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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