Observational Cohort of Pancreatic Echo-endoscopy

Obesity Clinical Trial

— OBELIX  

Official title:

Score of Echogenicity and Pancreatic Echo-endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04226014
• Other study ID #: OBELIX
• Status: Completed
• Start date: July 17, 2018
• Est. completion date: September 15, 2019

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 15, 2019
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis
• Metabolic Syndrome
• Obesity

Intervention

Procedure:
• Endoscopic 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.

Locations

Country	Name	City	State
France	Polyclinique du Beaujolais	Arnas
France	Clinique du Val d'Ouest	Écully
France	Hôpital privé Jean Mermoz	Lyon
France	Clinique du Trocadéro	Paris
France	Clinique des Portes du Sud	Vénissieux

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon	Clinique du Val d’ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of the pancreatic echogenicity by endoscopic ultrasound with the metabolic syndrome	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	Comparaison of the echogenicity of the pancreas with respect to the liver and to the spleen will be made.	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.	During the reading of the echo-endoscopic procedure