OBELIX: Observational Cohort of Pancreatic Echo-endoscopy

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT04226014

Collaborator

Clinique du Val d'ouest (Other)

Enrollment

Locations

Actual Duration (Months)

19.4

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Obesity Hepatic Steatosis	Procedure: Endoscopic ultrasound

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 Design

Study Type:

Observational

Actual Enrollment :

97 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Score of Echogenicity and Pancreatic Echo-endoscopy

Actual Study Start Date :

Jul 17, 2018

Actual Primary Completion Date :

Apr 16, 2019

Actual Study Completion Date :

Sep 15, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Patients with echo-endoscopic ultrasound of the pancreas

Patients requiring endoscopic ultrasound of the pancreas were included in the cohort.

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.

Outcome Measures

Primary Outcome Measures

Correlation of the pancreatic echogenicity by endoscopic ultrasound with the metabolic syndrome [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 Outcome Measures

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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Polyclinique du Beaujolais	Arnas	France	69400
2	Hôpital privé Jean Mermoz	Lyon	France	69008
3	Clinique du Trocadéro	Paris	France	75116
4	Clinique des Portes du Sud	Vénissieux	France	69694
5	Clinique du Val d'Ouest	Écully	France	69130