Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary DiseasesNCT06402305
Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases
An observational study of Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases, run by Alaa Mohamed Mostafa at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases
- What is being tested?
- Lipid profile
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2024to 5 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with adiagnosis of gall stones ,acute calcular cholecystitis,calcular obstructive jaundice ,biliary stricture ,acute and chronic pancreatitis.
Who may be able to join
- 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
Who cannot join
- Patients with renal failure, hemolytic diseases (hereditary spherocytosis, sickle cell anemia on history and CBC film).
- Patients on antihyperlipidemic drugs .
Trial locations and contacts
1 site in 1 country.
Asmaa N Mohammed, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university
Sohag
Magdy M Amin, Professor
About this study
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).
Read more
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)
- Being tested
- Lipid profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid profileDiagnostic test
Also called Abdominal ultrasound
Abdominal ultrasound and lipid profile will be done
| Study group | Role | What they receive |
|---|---|---|
| group A | Cases Receives: Diagnostic Test: Lipid profile | |
| group B | Controls Receives: Diagnostic Test: Lipid profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start2 May 2024
- Primary completion5 May 2024 (estimated)
- Study completion5 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaa Mohamed Mostafa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Mohamed Mostafa, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402305
- Sponsor's protocol ID
- Soh-Med-24-04-015MS
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 7817971Carr 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.
PubMed 27012480Crockett 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.
PubMed 29409760Halldestam 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.
PubMed 19847878
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases
- ClinicalTrials.gov ID
- NCT06402305
- Acronym / sponsor ID
- Soh-Med-24-04-015MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Alaa Mohamed MostafaUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 5 May 2024 (estimated)
- Study completion
- 5 May 2024 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Diagnostic Test: Lipid profileCases |
| group B | – | Diagnostic Test: Lipid profileControls |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with adiagnosis of gall stones ,acute calcular cholecystitis,calcular obstructive jaundice ,biliary stricture ,acute and chronic pancreatitis.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with renal failure, hemolytic diseases (hereditary spherocytosis, sickle cell anemia on history and CBC film).
- Patients on antihyperlipidemic drugs .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipid profileAlso: Abdominal ultrasoundAbdominal ultrasound and lipid profile will be done | Diagnostic test | group A, group B |
Primary outcome
Lipid Profile and Ultrasound Findings in Patients with Pancreaticobiliary Diseases
Time frame: 1 year
* To evaluate the lipid profile and ultrasound findings in biliary diseases * To assess the lipid profile and ultrasound findings in pancreatic diseases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 7817971Attili 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.
- Background: PubMed 27012480Carr 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.
- Background: PubMed 29409760Crockett 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.
- Background: PubMed 19847878Halldestam 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa N Mohammed, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases, run by Alaa Mohamed Mostafa at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa M Mostafa, Resident (01099143258, Alaa.Mohamed2015m@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Profile and Ultrasound Findings in Patients with Pancreaticobiliary Diseases (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06402305, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.