Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

NCT ID: NCT05557669

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-17
• Study Completion Date: 2025-03-30

Brief 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.

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.

Conditions

Cholelithiasis; Metabolic Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Investigation Group

Patients undergoing laparoscopic cholecystectomy for cholelithiasis

Group Type: EXPERIMENTAL

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

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

Control group

Patients with gallstone disease who are not planned for laparoscopic cholecystectomy in upcoming 3 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Laparoscopic cholecystectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• cholelithiasis

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jagiellonian University

OTHER

Sponsor Role: collaborator

Brothers Hospitallers Hospital in Cracow

OTHER

Sponsor Role: lead

Responsible Party

Zofia Orzeszko

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mirosław Szura, prof.

Role: STUDY_CHAIR

Jagiellonian University

Locations

Brothers Hospitallers Hospital in Cracow

Krakow, Lesser Poland Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Zofia Orzeszko

Role: CONTACT

zosia.orzeszko@icloud.com

+48123797148

Tomasz Gach, PhD

Role: CONTACT

tomasz.gach@uj.edu.pl

+48123797145

Facility Contacts

Zofia Orzeszko

Role: primary

z.orzeszko@bonifratrzy.krakow.pl

+48123797148

References

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.

Reference Type: BACKGROUND

PMID: 26256900 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32352682 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28892095 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29706426 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29297503 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30770629 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26143191 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31477078 (View on PubMed)

Other Identifiers

1072.6120.25.2021

Identifier Type: -

Identifier Source: org_study_id