Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-06 @ 7:31 PM
Study NCT ID:
NCT07263061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time to Post-operative Recovery of Serum Albumin as a Predictor of Outcome in Major Hepato Pancreato Biliary Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-11-22', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to recovery of serum albumin as a predictor of outcome in major hepatobiliary surgeries as measured by hospital stay.', 'timeFrame': '30 days', 'description': 'Time taken for unsupported albumin in Liver function test in a rising trend (g/dl)'}], 'secondaryOutcomes': [{'measure': 'To correlate the time to recovery of albumin with complications and morbidity (Clavien Dindo classification, Comprehensive Complication Index, Intensive Care Unit Stay)', 'timeFrame': '30 days', 'description': 'Major Complications measured by Clavien Dindo Classification (Major \\>grade 3A) and Comprehensive complication index (Major More than 27)'}, {'measure': 'Time to reversal trend of albumin and Hospital stay', 'timeFrame': '30 days', 'description': 'Time taken for unsupported albumin in Liver function test to reach a value of more than 3 g/dl and compared with the hospital stay'}, {'measure': 'correlation of time to recovery of albumin and re admission rates', 'timeFrame': '90 days', 'description': 'Time taken for unsupported albumin in Liver function test to reach a value of more than 3 g/dl and compared with the 90 day re admission rates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatobiliary Disease', 'Pancreas Disease', 'Bile Duct Diseases']}, 'descriptionModule': {'briefSummary': 'Hepatobiliary and Pancreatic surgery is associated with substantial risk of postoperative complications. Albumin is a negative acute phase protein. Its rapid decline may be due to degree of inflammation due to surgical procedures. The decline may due to multifactorial causes. Currently, contemporary data regarding the time to recovery of albumin, as a marker for early recovery of patient from surgical stress is sparse. Delta albumin is influenced by perioperative fluid administration and albumin supplementation. Delta albumin may not reflect the true surgical stress. Early post op albumin is a reflection of intraoperative events and not postoperative recovery or events and is unpredictable. Shorter recovery time of albumin is associated with less post op complications and hospital stay. Earlier recovery of albumin predicts lower morbidity and shorter hospital stay.', 'detailedDescription': 'Hepatobiliary and Pancreatic surgery is associated with substantial risk of postoperative complications. Albumin is a negative acute phase protein. Its rapid decline may be due to degree of inflammation due to surgical procedures. The decline may due to multifactorial causes. Currently, contemporary data regarding the time to recovery of albumin, as a marker for early recovery of patient from surgical stress is sparse. Delta albumin is influenced by perioperative fluid administration and albumin supplementation. Delta albumin may not reflect the true surgical stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing major Hepato pancreatico Biliary surgeries.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients undergoing major Hepato pancreatico Biliary surgeries.\n2. Patients who are more than 12 years of age\n3. Retrospective arm - Data from 2010\n\nExclusion Criteria:\n\n1. Patients who refuse or are unable to give consent.\n2. Patients with Nephrotic syndrome, Protein losing enteropathies, Inflammatory bowel\n3. Disease, Chronic Liver Disease.\n4. Emergency Surgeries'}, 'identificationModule': {'nctId': 'NCT07263061', 'briefTitle': 'Time to Post-operative Recovery of Serum Albumin as a Predictor of Outcome in Major Hepato Pancreato Biliary Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Time to Post-operative Recovery of Serum Albumin as a Predictor of Outcome in Major Hepato Pancreato Biliary Surgeries', 'orgStudyIdInfo': {'id': 'IEC/2024/110/MA04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hepatobiliary and pancreatic diseases', 'description': 'Patients undergoing Major Hepato Pancreato biliary surgeries', 'interventionNames': ['Other: NO TREATMENT']}], 'interventions': [{'name': 'NO TREATMENT', 'type': 'OTHER', 'description': 'NO TREATMENT', 'armGroupLabels': ['hepatobiliary and pancreatic diseases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'ILBS', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'Dr Rajagopalan G, DNB', 'role': 'CONTACT', 'email': 'prash1108@gmail.com', 'phone': '8220408324'}], 'overallOfficials': [{'name': 'Dr Ragini Kilambi, MCh', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ILBS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}