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Completed

NCT Number: NCT04226014

Observational Cohort of 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?

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Key information

Conditions

Metabolic Syndrome Body Weight Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hepatic Steatosis Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Polyclinique du Beaujolais, Arnas, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Ultrasound

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    • The visibility of Wirsung in three categories: excellent, average, poor
    • that of the contours in 3 categories good or average or poor visualization of the splenic vein
    • 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
    • with in addition a -heterogeneous or - homogeneous item for the parenchyma.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Other

Collaborators

  • Clinique du Val d'ouest

Registry information

Official study title

Score of Echogenicity and Pancreatic Echo-endoscopy

Acronym: OBELIX

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2020
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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