Observational Cohort of Pancreatic Echo-endoscopy

NCT04226014 | Completed

• 1 other identifier: OBELIX
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 5

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?

Conditions

Metabolic Syndrome; Obesity; Hepatic Steatosis

Keywords

pancreatic echogenecity; Hepatic Steatosis; Metabolic Syndrome; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Patients with echo-endoscopic ultrasound of the pancreas

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

Procedure: Endoscopic ultrasound

Interventions

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.

Patients with echo-endoscopic ultrasound of the pancreas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients with pancreatic and / or tissue damage with dilated wirsung canal and / or acute or chronic pancreatitis.
• Patients having contraindication to general anesthesia

Sponsors & Collaborators

• Centre Hospitalier Saint Joseph Saint Luc de Lyon: lead
• Clinique du Val d'ouest: collaborator

Study Sites (5)

Polyclinique du Beaujolais

Arnas, 69400, France

Location

Clinique du Val d'Ouest

Écully, 69130, France

Location

Hôpital privé Jean Mermoz

Lyon, 69008, France

Location

Clinique du Trocadéro

Paris, 75116, France

Location

Clinique des Portes du Sud

Vénissieux, 69694, France

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Fatty Liver

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Anne-Marie MARION-AUDIBERT, MD, PhD

  Clinique du Val d'ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: July 17, 2018
• Primary Completion: April 16, 2019
• Study Completion: September 15, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

FR (5)