Observational Cohort of Pancreatic Echo-endoscopy

NCT ID: NCT04226014

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-17

Study Completion Date

2019-09-15

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome Obesity Hepatic Steatosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with echo-endoscopic ultrasound of the pancreas

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

Endoscopic ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique du Val d'ouest

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Saint Joseph Saint Luc de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Marie MARION-AUDIBERT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinique du Val d'ouest

Locations

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Polyclinique du Beaujolais

Arnas, , France

Site Status

Clinique du Val d'Ouest

Écully, , France

Site Status

Hôpital privé Jean Mermoz

Lyon, , France

Site Status

Clinique du Trocadéro

Paris, , France

Site Status

Clinique des Portes du Sud

Vénissieux, , France

Site Status

Countries

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France

Other Identifiers

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OBELIX

Identifier Type: -

Identifier Source: org_study_id

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