Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Cholelithiasis
• Intervention / Treatment: Procedure: Laparoscopic cholecystectomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zofia Orzeszko; Phone Number: +48123797148; Email: zosia.orzeszko@icloud.com
• Study Contact Backup: Name: Tomasz Gach, PhD; Phone Number: +48123797145; Email: tomasz.gach@uj.edu.pl

Study Locations

• Poland
  • Lesser Poland
    • Kraków, Lesser Poland, Poland, 31061
      • Recruiting
      • Brothers Hospitallers Hospital in Cracow
      • Contact: Zofia Orzeszko; Phone Number: +48123797148; Email: z.orzeszko@bonifratrzy.krakow.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• cholelithiasis

Exclusion Criteria:

• metabolic syndrome
• obesity
• diabetes
• thyroid disease
• pancreatic disease
• serious abdominal surgeries in the past
• pregnancy, lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigation Group; Patients undergoing laparoscopic cholecystectomy for cholelithiasis	Procedure: Laparoscopic cholecystectomy; Laparoscopic cholecystectomy is a procedure of removal of the gallbladder and a gold standard in treatment of gallstone disease.
No Intervention: Control group; Patients with gallstone disease who are not planned for laparoscopic cholecystectomy in upcoming 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of the metabolic syndrome in patients undergoing laparoscopic cholecystectomy	Evaluated with the rNCEP criteria for metabolic syndrome.	3 months
incidence of central obesity	waist circumference in cm: men more or equal 102 cm; women more or equal 88 cm	3 months
incidence of triglyceridemia	serum triglycerides level in mg/dl: more or equal 150 mg/dl	3 months
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
incidence of systemic hypertension	blood preassure in mm Hg: more or equal 130 mm Hg/more or equal 85 mm Hg	3 months
incidence of glucose intolerance	fasting serum glucose in mg/dl: more or equal 100 mg/dl	3 months

Collaborators and Investigators

• Sponsor: Brothers Hospitallers Hospital in Cracow
• Collaborators: Jagiellonian University
• Investigators: Study Chair: Mirosław Szura, prof., Jagiellonian University

Publications and helpful links

General Publications

• 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.
• Barrera F, Azocar L, Molina H, Schalper KA, Ocares M, Liberona J, Villarroel L, Pimentel F, Perez-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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Anticipated): March 30, 2025
• Study Completion (Anticipated): March 30, 2025

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Pathological Conditions, Anatomical; Insulin Resistance; Hyperinsulinism; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Syndrome; Metabolic Syndrome; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: 1072.6120.25.2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No