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

Completed

Intervention / Treatment

Detailed Description

Little is known about the pathogenesis of the fatty pancreas. Fat can replace acinar cells and / or pancreatic endocrine cells (1). To date, there are no biomarkers allowing the detection of a fatty pancreas. It appears that older age, male, obesity, alcohol consumption, high triglycerides, high ALT, diabetes or insulin resistance, fatty liver and metabolic syndrome are risk factors for a fatty pancreas (2,3,4).To the investigator's knowledge, these different factors have not been evaluated on the impact of pancreatic echogenecity in endosonography. The objective of this study is to correlate the factors making up the metabolic syndrome with pancreatic echogenecity.

Study Type

Observational

Enrollment (Actual)

97

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

      • Arnas, France, 69400
        • Polyclinique du Beaujolais
      • Lyon, France, 69008
        • Hopital Prive Jean Mermoz
      • Paris, France, 75116
        • Clinique du Trocadero
      • Vénissieux, France, 69694
        • Clinique des Portes du Sud
      • Écully, France, 69130
        • Clinique Du Val D'Ouest

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient receiving a high echo-endography meeting the inclusion criteria will be included.

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

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
Intervention / Treatment
Patients with echo-endoscopic ultrasound of the pancreas
Patients requiring endoscopic ultrasound of the pancreas were included in the cohort.
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.

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
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
During the reading of the echo-endoscopic procedure

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

The pancreatic echogenicity score will be assessed with the following criteria

  1. The visibility of Wirsung in three categories: excellent, average, poor
  2. that of the contours in 3 categories good or average or poor visualization of the splenic vein
  3. that of the parenchyma in 3 categories: normal, brilliant, not too obstructing the visualization of the Wirsung and the splenic vein, very promising embarrassing the visualization of the Wirsung and the splenic vein
  4. with in addition a -heterogeneous or - homogeneous item for the parenchyma.
During the reading of the echo-endoscopic procedure

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Anne-Marie MARION-AUDIBERT, MD, PhD, Clinique Du Val D'Ouest

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 (Actual)

July 17, 2018

Primary Completion (Actual)

April 16, 2019

Study Completion (Actual)

September 15, 2019

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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