NCT05557669

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

4.1 years

First QC Date

July 25, 2022

Last Update Submit

September 27, 2022

Conditions

CholelithiasisMetabolic Syndrome

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Investigation Group

EXPERIMENTAL

Patients undergoing laparoscopic cholecystectomy for cholelithiasis

Procedure: Laparoscopic cholecystectomy

Control group

NO INTERVENTION

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

Interventions

Laparoscopic cholecystectomyPROCEDURE

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

Investigation Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cholelithiasis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brothers Hospitallers Hospital in Cracow

Krakow, Lesser Poland Voivodeship, 31061, Poland

RECRUITING

Related Publications (8)

  • 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.

    PMID: 26256900BACKGROUND

  • 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.

    PMID: 32352682BACKGROUND

  • 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.

    PMID: 28892095BACKGROUND

  • 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.

    PMID: 29706426BACKGROUND

  • 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.

    PMID: 29297503BACKGROUND

  • 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.

    PMID: 30770629BACKGROUND

  • 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.

    PMID: 26143191BACKGROUND

  • 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.

    PMID: 31477078BACKGROUND

MeSH Terms

Conditions

CholelithiasisMetabolic Syndrome

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Mirosław Szura, prof.

    Jagiellonian University

    STUDY CHAIR

Central Study Contacts

Zofia Orzeszko

CONTACT

+48123797148zosia.orzeszko@icloud.com

Tomasz Gach, PhD

CONTACT

+48123797145tomasz.gach@uj.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2022

First Posted

September 28, 2022

Study Start

February 17, 2021

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)