Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-03-04 @ 10:55 PM
Study NCT ID:
NCT02644603
Status:
UNKNOWN
Last Update Posted:
2017-06-27
First Post:
2015-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2018-03-27', 'unreleaseDateUnknown': True}, {'releaseDate': '2018-04-02', 'unreleaseDateUnknown': True}, {'resetDate': '2018-12-06', 'releaseDate': '2018-04-30'}], 'estimatedResultsFirstSubmitDate': '2018-03-27'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080482', 'term': 'Enhanced Recovery After Surgery'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-24', 'studyFirstSubmitDate': '2015-12-15', 'studyFirstSubmitQcDate': '2015-12-30', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment related complications', 'timeFrame': 'Up to 1 month since operation', 'description': 'Number of adverse events that are related to treatment of each patients, and hospital readmission'}], 'secondaryOutcomes': [{'measure': 'Length of stay in hospital', 'timeFrame': 'From the day a patient be hospitalized to the day discharged, up to 1 month.', 'description': 'Length of stay in hospital (days)'}, {'measure': 'Total hospitalization costs', 'timeFrame': 'From the day a patient be hospitalized to the day discharged, up to 1 month.', 'description': 'Total hospitalization costs (RMB yuan).'}, {'measure': 'Preoperative and postoperative body weight', 'timeFrame': 'One day before operation, and the day patient discharged, up to 1 month.', 'description': "Patient's body weight in kg."}, {'measure': 'Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L),', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'Hb in g/L.'}, {'measure': 'Albumin (ALB)', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'ALB in g/L.'}, {'measure': 'PRE-Albumin (PRE-A)', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'PRE-A in g/L'}, {'measure': 'International Normalized Ratio (INR)', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'INR in seconds.'}, {'measure': 'Platelet (PLT)', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'PLT in 10\\^9/L'}, {'measure': 'Blood Urea Nitrogen (BUN)', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'BUN in mmol/L'}, {'measure': 'Blood Creatinine (sCr)', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'sCr in umol/L'}, {'measure': 'Alanine Transferase (ALT)', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'ALT in U/L'}, {'measure': 'Aspartate Transaminase (AST)', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'AST in U/L'}, {'measure': 'Interleukin-6 (IL-6)', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'IL-6 in (pg/ml)'}, {'measure': 'Interferon (IFN-γ)', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'IFN-γin pg/ml.'}, {'measure': 'Tumor necrosis factor-α (TNF-α)', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'TNF-αin pg/ml'}, {'measure': 'Serum complement', 'timeFrame': 'Day before operation and day 1/3/5 after operation.', 'description': 'C3 and C4 in mg/dl'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Enhanced Recovery After Surgery', 'hepatocellular carcinoma'], 'conditions': ['Carcinoma, Hepatocellular']}, 'referencesModule': {'references': [{'pmid': '16491462', 'type': 'BACKGROUND', 'citation': 'Sun HC, Qin LX, Lu L, Wang L, Ye QH, Ren N, Fan J, Tang ZY. Randomized clinical trial of the effects of abdominal drainage after elective hepatectomy using the crushing clamp method. Br J Surg. 2006 Apr;93(4):422-6. doi: 10.1002/bjs.5260.'}, {'pmid': '11222424', 'type': 'BACKGROUND', 'citation': 'Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.'}, {'pmid': '23562361', 'type': 'BACKGROUND', 'citation': 'Ni CY, Yang Y, Chang YQ, Cai H, Xu B, Yang F, Lau WY, Wang ZH, Zhou WP. Fast-track surgery improves postoperative recovery in patients undergoing partial hepatectomy for primary liver cancer: A prospective randomized controlled trial. Eur J Surg Oncol. 2013 Jun;39(6):542-7. doi: 10.1016/j.ejso.2013.03.013. Epub 2013 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate Enhanced Recovery After Surgery(ERAS) protocol versus conventional treatment on patients who underwent liver resection for hepatocellular carcinoma(HCC).', 'detailedDescription': "212 patients are randomly recruited from inpatients of Shanghai Zhongshan Hospital, Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Anhui Provincial Hospital, Subei People's Hospital of Jiangsu Province and Affiliated Tumor Hospital of Nantong University from February 2016 to July 2016. Randomly assigned about half of the patients to receive Enhanced Recovery After Surgery(ERAS) protocol and the other half to receive conventional treatment. Evaluate the safety and efficacy of the ERAS protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with HCC with indications for surgery\n* Without any surgical contraindications\n* Under went open liver resection\n* Operation ranges less than 4 hepatic segments\n* Informed consent\n\nExclusion Criteria:\n\n* Not suitable for surgery\n* Benign lesions or other lesions proved by pathology\n* Surgical procedure changed during operation or combined evisceration\n* Refused to participate or drop out'}, 'identificationModule': {'nctId': 'NCT02644603', 'briefTitle': 'Effect of Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer: a Multicenter, Randomized, Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'H-ERAS-MRCT-1511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Recovery After Surgery', 'description': 'Patients underwent ERAS protocol', 'interventionNames': ['Procedure: Enhanced Recovery After Surgery']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional Treatment', 'description': 'Patients underwent conventional treatment'}], 'interventions': [{'name': 'Enhanced Recovery After Surgery', 'type': 'PROCEDURE', 'otherNames': ['Fast Track Surgery'], 'description': 'Before operation:\n\nPreoperative optimization of organ function, No preoperative bowel preparation, Prohibit eating 6h, drinking water 2h before operation, Oral rehydration before operation.\n\nIn operation:\n\nOptimized combined anesthesia, Minimal invasive operations, Normothermia, Minimal use of tubes and drains.\n\nAfter operation:\n\nPostoperative analgesia and antiemetic, Early mobilization, Oral nutrition, Early and scheduled mobilization.', 'armGroupLabels': ['Enhanced Recovery After Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jian Zhou, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Zhongshan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eastern Hepatobiliary Surgery Hospital', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': "Subei People's Hospital of Jiangsu Province", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-03-27', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2018-04-02', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2018-04-30', 'type': 'RELEASE'}, {'date': '2018-12-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shanghai Zhongshan Hospital'}}}}