- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04226014
Observational Cohort of Pancreatic Echo-endoscopy (OBELIX)
Score of Echogenicity and Pancreatic Echo-endoscopy
Metabolic syndrome is defined by the presence of at least two of the following five criteria: abdominal perimeter> 94 cm in men, 80 cm in women, high triglycerides, low HDL cholesterol, HTA and hyperglycemia.
The metabolic syndrome can lead to ultrasound hepatic steatosis in 20 to 40% of cases depending on the population studied (overweight vs obesity). What is the impact of this syndrome on pancreatic echogenicity?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Arnas, France, 69400
- Polyclinique du Beaujolais
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Lyon, France, 69008
- Hopital Prive Jean Mermoz
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Paris, France, 75116
- Clinique du Trocadero
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Vénissieux, France, 69694
- Clinique des Portes du Sud
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Écully, France, 69130
- Clinique Du Val D'Ouest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- any consecutive patient, having a high echo-endoscopy
- for an extra pancreatic cause, such as the search for a cholelithiasis, (the pancreas will be studied completely)
- for esophageal pathologies, (the pancreas will be studied completely)
- for gastric pathologies, (the pancreas will be studied completely)
- for cystic lesions of the pancreas (pancreas studied upstream and downstream)
- for submucosal tumors (esophageal / gastric / duodenal)
- for abdominal pain of undetermined origin
Exclusion Criteria:
- Patients with pancreatic and / or tissue damage with dilated wirsung canal and / or acute or chronic pancreatitis.
- Patients having contraindication to general anesthesia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with echo-endoscopic ultrasound of the pancreas
Patients requiring endoscopic ultrasound of the pancreas were included in the cohort.
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Echo-endoscopy ultrasound is an examination that presents little risk.
However, any medical act, exploration, intervention even conducted under conditions of competence and safety in accordance with current data of medicine and the regulations in force, conceals a risk of complications.
In particular, esophageal perforations can occur.
They are often favored by underlying lesions (tumor, diverticulum, anatomical variants ...).
Other complications are possible such as cardiovascular, respiratory or infectious disorders, as with any anesthesia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of the pancreatic echogenicity by endoscopic ultrasound with the metabolic syndrome
Time Frame: During the reading of the echo-endoscopic procedure
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Three categories of echogenicity have been defined.
The presence of one or more factors of the metabolic syndrome was correlated with the category of pancreatic echogenicity defined by the experts
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During the reading of the echo-endoscopic procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparaison of the echogenicity of the pancreas with respect to the liver and to the spleen will be made.
Time Frame: During the reading of the echo-endoscopic procedure
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The pancreatic echogenicity score will be assessed with the following criteria
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During the reading of the echo-endoscopic procedure
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anne-Marie MARION-AUDIBERT, MD, PhD, Clinique Du Val D'Ouest
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBELIX
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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