Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-01-10 @ 1:53 PM
Study NCT ID:
NCT05970159
Status:
UNKNOWN
Last Update Posted:
2023-08-03
First Post:
2023-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Preoperative Serum Albumin Level on Postoperative Outcomes in Chinese HCC Patients Treated With Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2023-07-30', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Days of hospital stay', 'timeFrame': 'up to 2 weeks', 'description': 'The length of stay in hospital after surgery.'}, {'measure': 'Days of ICU stay', 'timeFrame': 'up to 4 weeks', 'description': 'The length of stay in ICU after surgery.'}], 'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'up to 2 weeks', 'description': 'Complications following surgery that occurred during hospitalization. For the hepatectomy cohort of patients, postoperative complications included incision, urinary tract and abdominal infections, pleural fluid, ascites, post-hepatectomy hemorrhage bile leakage, post hepatectomy liver failure, renal insufficiency, multiple organ dysfunction syndrome, pneumonia and pulmonary embolism, etc. For the LT cohort of patients, postoperative complications included primary nonfunction, hemorrhage, hepatic artery thrombosis, hepatic vein thrombosis, bile leakage, acute kidney injury, deep wound infections and catheter-related infections.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'up to 2 weeks', 'description': 'Death occurring during the postoperative hospital stay.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'Albumin', 'Hepatectomy', 'Liver transplantation', 'Postoperative outcomes'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '29113664', 'type': 'RESULT', 'citation': 'Ma KW, Cheung TT, She WH, Chok KSH, Chan ACY, Dai WC, Lo CM. Risk prediction model for major complication after hepatectomy for malignant tumour - A validated scoring system from a university center. Surg Oncol. 2017 Dec;26(4):446-452. doi: 10.1016/j.suronc.2017.08.007. Epub 2017 Sep 9.'}, {'pmid': '15383797', 'type': 'RESULT', 'citation': 'Poon RT, Fan ST, Lo CM, Liu CL, Lam CM, Yuen WK, Yeung C, Wong J. Improving perioperative outcome expands the role of hepatectomy in management of benign and malignant hepatobiliary diseases: analysis of 1222 consecutive patients from a prospective database. Ann Surg. 2004 Oct;240(4):698-708; discussion 708-10. doi: 10.1097/01.sla.0000141195.66155.0c.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational and retrospective cohort study to evaluate the impact of the preoperative serum albumin concentration on postoperative outcomes among hepatocellular carcinoma (HCC) patients who received hepatectomy or liver transplantation.', 'detailedDescription': 'The impact of hypoalbuminemia on postoperative outcomes has been the subject of several investigations which agreed that hypoalbuminemia is an important risk factor for mortality and morbidity after various types of surgical operations. Unfortunately, there are limited real-world data to establish the correlation between hypoalbuminemia and hepatectomy or liver transplantation postoperative complications in China. This study will evaluate the impact of the preoperative serum albumin concentration on postoperative outcomes among hepatocellular carcinoma (HCC) patients who received hepatectomy or liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who met the criteria for inclusion in this real-world study from Zhongshan Hospital, Fudan University will be included. According to a preliminary feasibility department investigation, a sample size of approximately 480 subjects will be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who diagnosed with HCC confirmed by histology/cytology or clinically criteria regardless of gender.\n* HCC Patients who had received the first hepatectomy or liver transplantation (LT).\n* Age ≥18 years at the start date of the hepatectomy or LT.\n* HCC patients who had the value of serum albumin within 7 days prior to the surgery.\n* HCC patients who had exemption of informed consent.\n\nExclusion Criteria:\n\n* HCC Patients with extrahepatic metastasis or other malignant tumours.'}, 'identificationModule': {'nctId': 'NCT05970159', 'acronym': 'REAL', 'briefTitle': 'Impact of Preoperative Serum Albumin Level on Postoperative Outcomes in Chinese HCC Patients Treated With Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'The Impacts of preopeRative sErum Albumin Levels on Postoperative Outcomes in Chinese HCC Patients Treated With Surgical Operation: REAL Study', 'orgStudyIdInfo': {'id': 'B2023-216'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypoalbuminemia group', 'description': 'Patients with hepatocellular carcinoma whose preoperative serum albumin concentration are \\< 36g/L.'}, {'label': 'Normal group', 'description': 'Patients with hepatocellular carcinoma whose preoperative serum albumin concentration are ≥ 36g/L.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Li', 'role': 'CONTACT', 'email': 'lihui0801@foxmail.com', 'phone': '+86-21-64041990'}, {'name': 'Huichuan Sun', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Huichuan Sun', 'role': 'CONTACT', 'email': 'sun.huichuan@zs-hospital.sh.cn', 'phone': '+86-21-64041990'}, {'name': 'Hui Li', 'role': 'CONTACT', 'email': 'lihui0801@foxmail.com', 'phone': '+86-21-64041990'}], 'overallOfficials': [{'name': 'Huichuan Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}