Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT05557669
Status:
UNKNOWN
Last Update Posted:
2022-09-28
First Post:
2022-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}], 'ancestors': [{'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-09-27', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of the metabolic syndrome in patients undergoing laparoscopic cholecystectomy', 'timeFrame': '3 months', 'description': 'Evaluated with the rNCEP criteria for metabolic syndrome.'}, {'measure': 'incidence of central obesity', 'timeFrame': '3 months', 'description': 'waist circumference in cm: men more or equal 102 cm; women more or equal 88 cm'}, {'measure': 'incidence of triglyceridemia', 'timeFrame': '3 months', 'description': 'serum triglycerides level in mg/dl: more or equal 150 mg/dl'}, {'measure': 'incidence of dyslipidemia', 'timeFrame': '3 months', 'description': 'serum high-density lipo-protein (HDL) level in md/dl: men less than 40 mg/dl; women less than 50 mg/dl'}, {'measure': 'incidence of systemic hypertension', 'timeFrame': '3 months', 'description': 'blood preassure in mm Hg: more or equal 130 mm Hg/more or equal 85 mm Hg'}, {'measure': 'incidence of glucose intolerance', 'timeFrame': '3 months', 'description': 'fasting serum glucose in mg/dl: more or equal 100 mg/dl'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholelithiasis', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '26256900', 'type': 'BACKGROUND', 'citation': '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': '32352682', 'type': 'BACKGROUND', '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.'}, {'pmid': '28892095', 'type': 'BACKGROUND', '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.'}, {'pmid': '29706426', 'type': 'BACKGROUND', '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.'}, {'pmid': '29297503', 'type': 'BACKGROUND', '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.'}, {'pmid': '30770629', 'type': 'BACKGROUND', '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.'}, {'pmid': '26143191', 'type': 'BACKGROUND', '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.'}, {'pmid': '31477078', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cholelithiasis\n\nExclusion Criteria:\n\n* metabolic syndrome\n* obesity\n* diabetes\n* thyroid disease\n* pancreatic disease\n* serious abdominal surgeries in the past\n* pregnancy, lactation'}, 'identificationModule': {'nctId': 'NCT05557669', 'briefTitle': 'Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Brothers Hospitallers Hospital in Cracow'}, 'officialTitle': 'Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome', 'orgStudyIdInfo': {'id': '1072.6120.25.2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigation Group', 'description': 'Patients undergoing laparoscopic cholecystectomy for cholelithiasis', 'interventionNames': ['Procedure: Laparoscopic cholecystectomy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients with gallstone disease who are not planned for laparoscopic cholecystectomy in upcoming 3 months'}], 'interventions': [{'name': 'Laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic cholecystectomy is a procedure of removal of the gallbladder and a gold standard in treatment of gallstone disease.', 'armGroupLabels': ['Investigation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31061', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Zofia Orzeszko', 'role': 'CONTACT', 'email': 'z.orzeszko@bonifratrzy.krakow.pl', 'phone': '+48123797148'}], 'facility': 'Brothers Hospitallers Hospital in Cracow', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'centralContacts': [{'name': 'Zofia Orzeszko', 'role': 'CONTACT', 'email': 'zosia.orzeszko@icloud.com', 'phone': '+48123797148'}, {'name': 'Tomasz Gach, PhD', 'role': 'CONTACT', 'email': 'tomasz.gach@uj.edu.pl', 'phone': '+48123797145'}], 'overallOfficials': [{'name': 'Mirosław Szura, prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Jagiellonian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brothers Hospitallers Hospital in Cracow', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jagiellonian University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zofia Orzeszko', 'investigatorAffiliation': 'Brothers Hospitallers Hospital in Cracow'}}}}