Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-26 @ 11:50 AM
Study NCT ID:
NCT04490668
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2020-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], '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': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000075462', 'term': 'Serum Albumin, Human'}], 'ancestors': [{'id': 'D012709', 'term': 'Serum Albumin'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1049}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-26', 'studyFirstSubmitDate': '2020-07-26', 'studyFirstSubmitQcDate': '2020-07-26', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the rate of anastomotic leakage', 'timeFrame': 'Up to one months after the discharge of last patient', 'description': 'The rate of anastomotic leakage were compared among both groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'Anastomotic leakage', 'Human albumin'], 'conditions': ['Gastric Cancer', 'Anastomotic Leak']}, 'descriptionModule': {'briefSummary': 'We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.', 'detailedDescription': 'Anastomotic leakage after gastric cancer surgery is not very common but it is a very critical postoperative complication. Anastomotic leakage severely compromises the recovery after surgery. It increases the overall burden of patients and hospital resources. Postoperative mortality is higher in patients with anastomotic leakage.\n\nHuman albumin is routinely administered after surgery with a unproven hypothesis that the human albumin is beneficial to prevent anastomotic leakage. We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with gastric cancer who underwent gastrectomy with adequate lymph node dissection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed gastric cancer\n* Patients who underwent radical gastrectomy\n\nExclusion Criteria:\n\n* Patient who did not undergo gastrectomy'}, 'identificationModule': {'nctId': 'NCT04490668', 'briefTitle': 'Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Association of Human Albumin With Anastomotic Leakage After Gastric Cancer Surgery', 'orgStudyIdInfo': {'id': 'RJ-GC-Postop-complication 3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Human albumin support', 'description': 'Patients who received intravenous human albumin after gastric cancer surgery', 'interventionNames': ['Biological: Human albumin']}, {'label': 'No human albumin support', 'description': 'Patients who did not receive intravenous human albumin after gastric cancer surgery', 'interventionNames': ['Biological: Human albumin']}], 'interventions': [{'name': 'Human albumin', 'type': 'BIOLOGICAL', 'description': 'Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.', 'armGroupLabels': ['Human albumin support', 'No human albumin support']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Birendra K Sah, PH D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Chen Li, PH D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Zhenggang Zhu, PH D', 'role': 'STUDY_CHAIR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'BIRENDRA KUMAR SAH', 'investigatorAffiliation': 'Ruijin Hospital'}}}}