Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-26 @ 11:01 PM
Study NCT ID:
NCT05088304
Status:
COMPLETED
Last Update Posted:
2021-10-21
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D009369', 'term': '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': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-10', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-10-10', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative complications', 'timeFrame': 'Within 60 days after surgery', 'description': 'postoperative complications (infectious complications and noninfectious complications)'}], 'secondaryOutcomes': [{'measure': 'length of stay (LOS)', 'timeFrame': 'Within 60 days after surgery', 'description': 'length of stay (LOS)'}, {'measure': 'wound healing time', 'timeFrame': 'Within 60 days after surgery', 'description': 'wound healing time'}, {'measure': 'postoperative antibiotic time', 'timeFrame': 'Within 60 days after surgery', 'description': 'postoperative antibiotic time'}, {'measure': 'nutritional status', 'timeFrame': 'up to 4 weeks', 'description': 'nutritional status ( such as: weight，albumin，prealbumin)'}, {'measure': 'hospitalization cost', 'timeFrame': 'Within 60 days after surgery', 'description': 'hospitalization cost(including: surgery and medicine costs)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FFIM', 'GLIM', 'Cancer', 'Postoperative complications'], 'conditions': ['Cancer of Stomach', 'Cancer of Esophagus', 'Malnutrition', 'Muscle Loss']}, 'descriptionModule': {'briefSummary': 'The present study aims to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the Global Leadership Initiative on Malnutrition (GLIM) criteria.', 'detailedDescription': 'The GLIM criteria of malnutrition as a consensus lack of optimal combination in clinical validation. After the publication of the GLIM consensus, few studies have examined the effect of reduced FFMI on the clinical prognosis of patients with esophagogastric cancer, and whether the FFMI can be used as an effective diagnostic criterion of malnutrition in esophagogastric cancer needs to be further studied.\n\nTherefore, the present study aims were to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the GLIM consensus for malnutrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nElective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery); NRS2002≥3; Preoperative BIA examination was performed.\n\nExclusion Criteria:\n\nDischarged from a hospital within 24 hours; No BIA examination and not suitable for BIA examination (such as ascites, edema, amputation and pace-maker); Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin\\>3mg/dL) ; Renal insufficiency (serum creatinine\\>1.5mg/dL); Emergency operation; Pregnancy; Missing the postoperative information follow-up data.'}, 'identificationModule': {'nctId': 'NCT05088304', 'briefTitle': 'GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'The Application Value of Preoperative Fat-free Mass Index Within GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer', 'orgStudyIdInfo': {'id': 'JinlingHospital-1'}, 'secondaryIdInfos': [{'id': '201502022', 'type': 'OTHER_GRANT', 'domain': 'Research Special Fund for Public Welfare Industry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'The normal FFMI group', 'description': 'The FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, \\</≥15 kg/m2 for females and \\</≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the normal FFMI group (FFMI ≥17 kg/m2 for male and FFMI ≥15 kg/m2 for female).', 'interventionNames': ['Other: no intervention']}, {'label': 'The low FFMI group', 'description': 'The FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, \\</≥15 kg/m2 for females and \\</≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the low FFMI group (FFMI \\<17 kg/m2 for male and FFMI \\<15 kg/m2 for female).', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'armGroupLabels': ['The low FFMI group', 'The normal FFMI group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinling Hospital, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jiangsu Cancer Institute & Hospital', 'class': 'OTHER'}, {'name': "Subei People's Hospital of Jiangsu Province", 'class': 'OTHER'}, {'name': 'Peking Union Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wang Xinying', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}