Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases

NCT06402305 | Recruiting

• 1 other identifier: Soh-Med-24-04-015MS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Gall stones happen is the most prevalent pathology affecting the biliary system due to its Physiological function of concentration of bile having a prevalence of 10%-15% and an incidence of 1.4% per year in the adult population of developed countries (Halldestam et al,. 2009). Women are more commonly affected by gall stone disease as compared to men (Attili et al,. 1995). Multiple risk factors responsible for the Gall stone formation include modifiable factors such as lifestyle factors (reduced physical activity, rapid weight loss, fasting, and oral contraceptives (Di Ciaula et al,. 2013); dietary factors (high fat, high cholesterol, high refined carbohydrates, and low fiber ; metabolic syndrome (obesity, diabetes mellitus, dyslipidemia, and hyperinsulinemia (Cuevas et al., 2004). Among all the above mentioned risk factors, serum lipids are considered to be the most important risk factor involved in the pathogenesis of Gall stone disease (Celika et al,. 2015). Hyperlipidemia is generally characterized by high serum levels of total cholesterol, triglycerides, low density lipoproteins (LDL-C), and low levels of high-density lipoprotein (HDL-C). Some studies have showed a significant association of hyperlipidemia with gall stones especially hypertriglyceridemia and increased LDL-C levels (Rao et al,. 2012). Acute pancreatitis (AP) is an inflammatory condition of the pancreas that originates within the pancreatic acinar cells and causes pancreatic necrosis, systemic inflammatory response syndrome, and multiple organ failure (Crockett et al,. 2013). According to The revised Atlanta classification system from 2012 ,AP is diagnosed on the basis of two of three criteria-typically belt-like abdominal pain, an elevated serum lipase level three times above the normal threshold, and radiological imaging signs of pancreatitis (Parniczky et al,.2016). Severe hypertriglyceridemia is a well-known cause of AP. Recent studies have suggested that elevated serum triglyceride and low high-density lipoprotein cholesterol (HDL-C) levels are associated with persistent organ failure in acute pancreatitis (Peng et al,. 2015). With the change of people's diet structure and lifestyle, the incidence and mortality of hypertriglyceridemic AP are increasing year by year and has surpassed alcohol as the second leading cause of AP (Carr et al,. 2016). Chronic pancreatitis is a syndrome characterized by chronic progressive pancreatic inflammation, fibrosis, and scarring, resulting in damage to and loss of exocrine (acinar), endocrine (islet cells), and ductal cells(Majumder S,. 2016)

Conditions

Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases

Outcome Measures

Primary Outcomes (1)

• Lipid Profile and Ultrasound Findings in Patients with Pancreaticobiliary Diseases

  * To evaluate the lipid profile and ultrasound findings in biliary diseases * To assess the lipid profile and ultrasound findings in pancreatic diseases

  1 year

Study Arms (2)

group A

Cases

Diagnostic Test: Lipid profile

group B

Controls

Diagnostic Test: Lipid profile

Interventions

Lipid profile DIAGNOSTIC_TEST

Abdominal ultrasound and lipid profile will be done

Also known as: Abdominal ultrasound

group A; group B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with adiagnosis of gall stones ,acute calcular cholecystitis,calcular obstructive jaundice ,biliary stricture ,acute and chronic pancreatitis.

You may qualify if:

• Patients with age above 18 years
• Patients with confirmed diagnosis of gall stones ,acute calcular cholecystitis ,calcular obstructive jaundice ,biliary stricture ,acute and chronic pancreatitis

You may not qualify if:

• Patients with renal failure, hemolytic diseases (hereditary spherocytosis, sickle cell anemia on history and CBC film).
• Patients on antihyperlipidemic drugs .

Sponsors & Collaborators

• Alaa Mohamed Mostafa: lead

Study Sites (1)

Sohag university

Sohag, Egypt

RECRUITING

Related Publications (4)

• Attili AF, Carulli N, Roda E, Barbara B, Capocaccia L, Menotti A, Okoliksanyi L, Ricci G, Capocaccia R, Festi D, et al. Epidemiology of gallstone disease in Italy: prevalence data of the Multicenter Italian Study on Cholelithiasis (M.I.COL.). Am J Epidemiol. 1995 Jan 15;141(2):158-65. doi: 10.1093/oxfordjournals.aje.a117403.

  PMID: 7817971 BACKGROUND

• Carr RA, Rejowski BJ, Cote GA, Pitt HA, Zyromski NJ. Systematic review of hypertriglyceridemia-induced acute pancreatitis: A more virulent etiology? Pancreatology. 2016 Jul-Aug;16(4):469-76. doi: 10.1016/j.pan.2016.02.011. Epub 2016 Mar 3.

  PMID: 27012480 BACKGROUND

• Crockett SD, Wani S, Gardner TB, Falck-Ytter Y, Barkun AN; American Gastroenterological Association Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on Initial Management of Acute Pancreatitis. Gastroenterology. 2018 Mar;154(4):1096-1101. doi: 10.1053/j.gastro.2018.01.032. Epub 2018 Feb 3. No abstract available.

  PMID: 29409760 BACKGROUND

• Halldestam I, Kullman E, Borch K. Incidence of and potential risk factors for gallstone disease in a general population sample. Br J Surg. 2009 Nov;96(11):1315-22. doi: 10.1002/bjs.6687.

  PMID: 19847878 BACKGROUND

Central Study Contacts

Alaa M Mostafa, Resident

CONTACT

01099143258; Alaa.Mohamed2015m@med.sohag.edu.eg

Asmaa N Mohammed, Professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident in Tropical Medicine and Gastroenterology Department Sohag University Hospital

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: May 2, 2024
• Primary Completion: May 5, 2024
• Study Completion: May 5, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

EG (1)