Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT04791293
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2021-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Model for End-Stage Liver Disease Sodium (MELD-Na) Score in Non-cirrhotic Patients With Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-05', 'studyFirstSubmitDate': '2021-03-06', 'studyFirstSubmitQcDate': '2021-03-06', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MELD-Na score difference between the groups', 'timeFrame': '30 days', 'description': 'Importance of MELD-Na score in predicting postoperative complications in patients with gastric cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer', 'Complication,Postoperative', 'Complications; Gastrointestinal, Postoperative', 'Morality']}, 'referencesModule': {'references': [{'pmid': '30463752', 'type': 'BACKGROUND', 'citation': 'Coakley KM, Sarasani S, Prasad T, Steele SR, Paquette I, Heniford BT, Davis BR. MELD-Na Score as a Predictor of Anastomotic Leak in Elective Colorectal Surgery. J Surg Res. 2018 Dec;232:43-48. doi: 10.1016/j.jss.2018.04.012. Epub 2018 Jul 2.'}, {'pmid': '30446849', 'type': 'BACKGROUND', 'citation': 'Schlosser KA, Kao AM, Zhang Y, Prasad T, Kasten KR, Davis BR, Heniford BT, Colavita PD. MELD-Na score associated with postoperative complications in hernia repair in non-cirrhotic patients. Hernia. 2019 Feb;23(1):51-59. doi: 10.1007/s10029-018-1849-2. Epub 2018 Nov 16.'}, {'pmid': '30671898', 'type': 'BACKGROUND', 'citation': 'Yasri S, Wiwanitkit V. MELD-Na score and postoperative complications in hernia repair. Hernia. 2019 Aug;23(4):823. doi: 10.1007/s10029-019-01886-z. Epub 2019 Jan 22. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Gastric cancer is the fifth most common cancer worldwide. Gastrectomy with lymphadenectomy is still the most effective treatment modality, depending on the stage and location. Despite many radiological, surgical and anesthetic innovations, serious complications such as anastomotic leakage, intra-abdominal abscesses, wound complications are seen secondary to gastrectomy. Many clinical studies have been conducted to prevent and predict these complications.\n\nThe Model for End-Stage Liver Disease (MELD) score, in which bilirubin, international normalized ratio (INR) and serum creatinine values were used to determine surgical risks in patients scheduled for liver transplantation. Latter developed by adding serum sodium (Na) to the formula. The MELD-Na score is used to predict postoperative complications in non-cirrhotic patients because of its simple and easy calculation.Moreover, The Meld-Na score was later used to predict complications for surgical procedures other than liver surgery such as colorectal surgery.\n\nIn this study, we aimed to investigate the importance of the Meld-Na score in predicting the perioperative and postoperative outcomes in patients with gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing gastrectomy due to gastric cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing gastrectomy due to gastric cancer\n\nExclusion Criteria:\n\n* Patients with pulmonary, hepatic and renal disfunctions,\n* Patients with diagnosed with a different cancer in the last 5 years and\n* Pregnant patients'}, 'identificationModule': {'nctId': 'NCT04791293', 'briefTitle': 'The Model for End-Stage Liver Disease Sodium (MELD-Na) Score in Non-cirrhotic Patients With Gastric Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Training and Research Hospital'}, 'officialTitle': 'Predictive Value of MELD-Na Score for Perioperative Complications in Non-cirrhotic Patients With Gastric Cancer', 'orgStudyIdInfo': {'id': '2630'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients with postoperative complications', 'interventionNames': ['Other: MELD-Na score']}, {'label': 'Group 2', 'description': 'Patients without postoperative complications', 'interventionNames': ['Other: MELD-Na score']}], 'interventions': [{'name': 'MELD-Na score', 'type': 'OTHER', 'description': 'MELD-Na scores will be compared between the groups', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34029', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Cihad Tatar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Cihad Tatar', 'investigatorAffiliation': 'Istanbul Training and Research Hospital'}}}}