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Observational Cohort of Pancreatic Echo-endoscopy

Score of Echogenicity and Pancreatic Echo-endoscopy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04226014
Acronym
OBELIX
Enrollment
97
Registered
2020-01-13
Start date
2018-07-17
Completion date
2019-09-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Steatosis, Metabolic Syndrome, Obesity

Keywords

pancreatic echogenecity, Hepatic Steatosis, Metabolic Syndrome, Obesity

Brief summary

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?

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.

Interventions

PROCEDUREEndoscopic ultrasound

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.

Sponsors

Clinique du Val d'ouest
CollaboratorUNKNOWN
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of the pancreatic echogenicity by endoscopic ultrasound with the metabolic syndromeDuring the reading of the echo-endoscopic procedureThree 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

MeasureTime frameDescription
Comparaison of the echogenicity of the pancreas with respect to the liver and to the spleen will be made.During the reading of the echo-endoscopic procedureThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026