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CholelithiasisNCT05557669

Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

A study testing Laparoscopic cholecystectomy in people with Cholelithiasis and Metabolic Syndrome, run by Brothers Hospitallers Hospital in Cracow at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Cholelithiasis, Metabolic Syndrome
What is being tested?
Laparoscopic cholecystectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 sitePoland
Study dates
17 Feb 2021to 30 Mar 2025
Phase
Interventional
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • cholelithiasis

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Zofia Orzeszko contact

+48123797148

zosia.orzeszko@icloud.com

Tomasz Gach, PhD contact

+48123797145

tomasz.gach@uj.edu.pl

Poland1 site, 1 recruiting

  • Brothers Hospitallers Hospital in Cracow

    Krakow, Lesser Poland Voivodeship, 31061

    Zofia Orzeszko, +48123797148, z.orzeszko@bonifratrzy.krakow.pl

    Recruiting

Other trials in Poland

About this study

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.

Read the 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.

Being tested
Laparoscopic cholecystectomy
Medical subject headings
Cholelithiasis, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic cholecystectomyProcedure or surgery

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

Study groups in NCT05557669
Study groupRoleWhat they receive
Investigation GroupExperimentalPatients undergoing laparoscopic cholecystectomy for cholelithiasis
Receives: Procedure: Laparoscopic cholecystectomy
Control groupNo interventionPatients with gallstone disease who are not planned for laparoscopic cholecystectomy in upcoming 3 months

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Risk of the metabolic syndrome in patients undergoing laparoscopic cholecystectomy

    Evaluated with the rNCEP criteria for metabolic syndrome.

    Measured: 3 months

  2. incidence of central obesity

    waist circumference in cm: men more or equal 102 cm; women more or equal 88 cm

    Measured: 3 months

  3. incidence of triglyceridemia

    serum triglycerides level in mg/dl: more or equal 150 mg/dl

    Measured: 3 months

  4. 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

    Measured: 3 months

  5. incidence of systemic hypertension

    blood preassure in mm Hg: more or equal 130 mm Hg/more or equal 85 mm Hg

    Measured: 3 months

  6. incidence of glucose intolerance

    fasting serum glucose in mg/dl: more or equal 100 mg/dl

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2022
  2. Study start17 Feb 2021
  3. Primary completion30 Mar 2025 (estimated)
  4. Study completion30 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557669
Sponsor's protocol ID
1072.6120.25.2021
Status last verified
Sep 2022
First submitted
25 Jul 2022
Last updated
28 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26256900

  • 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.

    PubMed 32352682

  • 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.

    PubMed 28892095

  • 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.

    PubMed 29706426

  • 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.

    PubMed 29297503

  • 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.

    PubMed 30770629

  • 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.

    PubMed 26143191

  • 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.

    PubMed 31477078

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic cholecystectomy in people with Cholelithiasis and Metabolic Syndrome, run by Brothers Hospitallers Hospital in Cracow at 1 site in Poland.

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 1 inclusion and 7 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 28 Sep 2022. 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 Poland. 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 Zofia Orzeszko (+48123797148, zosia.orzeszko@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk of the metabolic syndrome in patients undergoing laparoscopic cholecystectomy (time frame: 3 months). The study lists 6 primary outcomes in all. 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 NCT05557669, which also lists 8 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 28 Sep 2022.

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