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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05557669
Other study ID # 1072.6120.25.2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 17, 2021
Est. completion date March 30, 2025

Study information

Verified date September 2022
Source Brothers Hospitallers Hospital in Cracow
Contact Zofia Orzeszko
Phone +48123797148
Email zosia.orzeszko@icloud.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective cohort study. POPULATION: patients with gallstone disease qualified for laparoscopic cholecystectomy INTERVENTION: patients undergoing cholecystectomy for gallstones COMPARISON: gallstone disease without surgery in an observation period OUTCOME: metabolic syndrome symptoms evaluated in 3 months period The main inclusion criteria is cholelithiasis confirmed by ultrasound examination in patients between 18-75 years old. The main exclusion criteria are metabolic syndrome, diabetes, thyroid diseases, pancreatic diseases, serious abdominal surgeries in the past, pregnancy, and lactation. Participants who qualified for laparoscopic cholecystectomy in 3 months are included in the investigation group. Those not having cholecystectomy planned in the upcoming three months for any reason (no consent for surgery, long term) are included in the control group. The intervention is to assess all metabolic syndrome criteria (blood pressure, glucose tolerance, dyslipidemia, abdominal obesity) before and three months after surgery. The endpoint is to evaluate if the risk of metabolic syndrome after cholecystectomy is higher than in patients with gallstones.


Description:

Laparoscopic cholecystectomy is well known as a gold standard of treatment for gallstone disease. Gallbladder removal is one of the most common procedures in the United States, with more than 1.2 million cholecystectomies per year, and 92% of the procedures are performed laparoscopically. In 2011 Amigo et al. reported increased triglyceride levels in mice after cholecystectomy. According to Ruhl et al. (2013), cholecystectomy is associated with an increased risk of non-alcoholic fatty liver disease that is considered a liver manifestation of metabolic syndrome. In 2014, Shen et al. published a retrospective study enrolling 5672 participants that demonstrated an increased risk of metabolic syndrome after cholecystectomy compared with gallstone disease alone. Metabolic syndrome (MS) is a disease of civilization. It is a group of disorders containing impaired glucose intolerance, hypertension, abdominal obesity, and dyslipidemia. According to meta-analysis, individuals reaching the criteria of metabolic syndrome have a twice higher risk of myocardial infarction or stroke and a 1,5-times higher risk of death for any reason. The study aims to assess the risk of metabolic syndrome after laparoscopic cholecystectomy prospectively.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date March 30, 2025
Est. primary completion date March 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - cholelithiasis Exclusion Criteria: - metabolic syndrome - obesity - diabetes - thyroid disease - pancreatic disease - serious abdominal surgeries in the past - pregnancy, lactation

Study Design


Intervention

Procedure:
Laparoscopic cholecystectomy
Laparoscopic cholecystectomy is a procedure of removal of the gallbladder and a gold standard in treatment of gallstone disease.

Locations

Country Name City State
Poland Brothers Hospitallers Hospital in Cracow Kraków Lesser Poland

Sponsors (2)

Lead Sponsor Collaborator
Brothers Hospitallers Hospital in Cracow Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (8)

Barrera F, Azócar L, Molina H, Schalper KA, Ocares M, Liberona J, Villarroel L, Pimentel F, Pérez-Ayuso RM, Nervi F, Groen AK, Miquel JF. Effect of cholecystectomy on bile acid synthesis and circulating levels of fibroblast growth factor 19. Ann Hepatol. 2015 Sep-Oct;14(5):710-21. — View Citation

Chen Y, Wu S, Tian Y. Cholecystectomy as a risk factor of metabolic syndrome: from epidemiologic clues to biochemical mechanisms. Lab Invest. 2018 Jan;98(1):7-14. doi: 10.1038/labinvest.2017.95. Epub 2017 Sep 11. Review. — View Citation

Di Ciaula A, Garruti G, Wang DQ, Portincasa P. Cholecystectomy and risk of metabolic syndrome. Eur J Intern Med. 2018 Jul;53:3-11. doi: 10.1016/j.ejim.2018.04.019. Epub 2018 Apr 26. Review. — View Citation

Garruti G, Wang DQ, Di Ciaula A, Portincasa P. Cholecystectomy: a way forward and back to metabolic syndrome? Lab Invest. 2018 Jan;98(1):4-6. doi: 10.1038/labinvest.2017.129. — View Citation

Latenstein CSS, Alferink LJM, Darwish Murad S, Drenth JPH, van Laarhoven CJHM, de Reuver PR. The Association Between Cholecystectomy, Metabolic Syndrome, and Nonalcoholic Fatty Liver Disease: A Population-Based Study. Clin Transl Gastroenterol. 2020 Apr;11(4):e00170. doi: 10.14309/ctg.0000000000000170. — View Citation

Qi L, Tian Y, Chen Y. Gall bladder: The metabolic orchestrator. Diabetes Metab Res Rev. 2019 Jul;35(5):e3140. doi: 10.1002/dmrr.3140. Epub 2019 Feb 27. Review. — View Citation

Tsai MS, Lin CL, Hsu YC, Lee HM, Kao CH. Long-term risk of pancreatitis and diabetes after cholecystectomy in patients with cholelithiasis but no pancreatitis history: a 13-year follow-up study. Eur J Intern Med. 2015 Sep;26(7):540-4. doi: 10.1016/j.ejim.2015.06.013. Epub 2015 Jul 2. — View Citation

Yue W, Sun X, Du T. Cholecystectomy versus central obesity or insulin resistance in relation to the risk of nonalcoholic fatty liver disease: the third US National Health and Nutrition Examination Survey. BMC Endocr Disord. 2019 Sep 2;19(1):95. doi: 10.1186/s12902-019-0423-y. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Risk of the metabolic syndrome in patients undergoing laparoscopic cholecystectomy Evaluated with the rNCEP criteria for metabolic syndrome. 3 months
Primary incidence of central obesity waist circumference in cm: men more or equal 102 cm; women more or equal 88 cm 3 months
Primary incidence of triglyceridemia serum triglycerides level in mg/dl: more or equal 150 mg/dl 3 months
Primary incidence of dyslipidemia serum high-density lipo-protein (HDL) level in md/dl: men less than 40 mg/dl; women less than 50 mg/dl 3 months
Primary incidence of systemic hypertension blood preassure in mm Hg: more or equal 130 mm Hg/more or equal 85 mm Hg 3 months
Primary incidence of glucose intolerance fasting serum glucose in mg/dl: more or equal 100 mg/dl 3 months
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