Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT05837793
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2023-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modified Frailty Index for Minimally Invasive Distal Pancreatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-19', 'studyFirstSubmitDate': '2023-04-19', 'studyFirstSubmitQcDate': '2023-04-19', 'lastUpdatePostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative outcomes', 'timeFrame': '6 months', 'description': 'Comparison of the Postoperative outcomes according to the mFI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Complication']}, 'referencesModule': {'references': [{'pmid': '37598358', 'type': 'DERIVED', 'citation': 'Park Y, Hwang DW, Lee JH, Song KB, Jun E, Lee W, Kwak BJ, Kim SC. Evaluation of postoperative outcomes of minimally invasive distal pancreatectomy for left-sided pancreatic tumors based on the modified frailty index: a retrospective cohort study. Int J Surg. 2023 Nov 1;109(11):3497-3505. doi: 10.1097/JS9.0000000000000670.'}]}, 'descriptionModule': {'briefSummary': "This study aims to investigate the difference in postoperative complications according to the modified Frailty Index (mFI) in patients who underwent minimally invasive distal pancreatectomy for pancreatic tumors at the Asan Medical Center's Department of Hepato-Biliary-Pancreatic Surgery from 2005 to 2019. It also seeks to confirm the utility of mFI as a predictive factor for postoperative complications in frail patients in the future.", 'detailedDescription': 'Distal pancreatectomy is a surgery performed to treat tumors in the distal pancreas. The minimally invasive approach to this surgery has become the standard due to its shorter hospital stay, quicker recovery, less pain, and similar complication rates compared to open surgery, especially for benign tumors. In selected patients with malignant tumors, minimally invasive distal pancreatectomy has gradually expanded to a state where it is not inferior to open surgery in terms of postoperative complications and long-term prognosis. As the average lifespan increases, elderly patients with comorbidities are steadily increasing in numbers among those who undergo distal pancreatectomy. However, predicting postoperative complications and mortality rates for these patients is still difficult. Simple yet effective predictive factors for postoperative complications are needed. The Canadian Study of Health and Aging has created a standardized frailty index (CSHA-FI) as a tool for predicting frailty in elderly patients, and a modified Frailty Index (mFI) has been developed for easy use. The mFI has been reported as a predictor of postoperative morbidity and mortality rates after colorectal and vascular surgery. This study aims to investigate whether mFI can be used as a predictive factor for postoperative morbidity and mortality rates in patients who undergo minimally invasive distal pancreatectomy and to utilize it for clinical treatment in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study aims to investigate the trend of frailty among patients who underwent minimally invasive pancreaticoduodenectomy for pancreatic head tumors between January 2005 and December 2019, using data collected until October 31, 2022. Based on an estimated 150 surgeries per year, the sample size is expected to be around 2000 patients. Frailty will be defined as mFI of 0.27 or higher, with an estimated prevalence of 3% among this patient population. The study will analyze the differences and severity of postoperative complications between frail and non-frail patients, while also examining the trend of frailty over the 15-year period. The expected sample size for the study is around 2000 patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study population consists of patients who underwent minimally invasive distal pancreatectomy for pancreatic body or tail tumors between January 2005 and December 2019.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05837793', 'briefTitle': 'Modified Frailty Index for Minimally Invasive Distal Pancreatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Evaluation of Postoperative Outcomes of Minimally Invasive Distal Pancreatectomy for Left-sided Pancreatic Tumors Based on the Modified Frailty Index: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '2022-1709'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'frail', 'description': 'The mFi categorizes patients with a score of 0.27 or higher as frail and those with a score below that as the non-frail group.', 'interventionNames': ['Behavioral: Modified frailty index']}, {'label': 'and non-frail', 'description': 'The mFi categorizes patients with a score of 0.27 or higher as frail and those with a score below that as the non-frail group.', 'interventionNames': ['Behavioral: Modified frailty index']}], 'interventions': [{'name': 'Modified frailty index', 'type': 'BEHAVIORAL', 'description': 'The mFI includes the following 11 items from the National Surgical Quality Improvement Program (NSQIP): diabetes; functional status (not independent); chronic obstructive pulmonary disease (COPD) or pneumonia; congestive heart failure; history of myocardial infarction; hypertension requiring medication; peripheral vascular disease or rest pain; impaired sensorium; history of either transient ischemic attack or cerebrovascular accident; history of cerebrovascular accident with neurologic deficit; and prior percutaneous coronary intervention, previous coronary surgery, or history of angina.', 'armGroupLabels': ['and non-frail', 'frail']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ks013', 'city': 'Seoul', 'state': 'Republic of Korea', 'country': 'South Korea', 'facility': 'Asan medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Song Cheol Kim, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Song Cheol Kim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Song Cheol Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}