Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:50 PM
Study NCT ID:
NCT07395635
Status:
RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Trial of Immunonutrition in Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D000093702', 'term': 'Immunonutrition Diet'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Not Applicable open labelled study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open labelled, Phase II randomized controlled trial Interventional Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-06', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative immunonutrition improves prognostic nutritional index (PNI)', 'timeFrame': '90 days', 'description': 'improvement in prognostic nutritional index after maor hepatectomies calculated with the help of Prognostic Nutritional Index (PNI) = \\[(10 × serum albumin (g/dL)) + (0.005 × total lymphocyte count)\\].'}], 'secondaryOutcomes': [{'measure': 'Incidence of postoperative complications', 'timeFrame': 'upto 3 months', 'description': 'number of complications in both arm major with Clavien-Dindo (CD) classification for adverse events 2. Incidence of post-hepatectomies liver failure (PHLF) 3. Length of ICU stay 4. Length of hospital stay, 5. Incidence of 90 days mortality'}, {'measure': 'Incidence of post-hepatectomies liver failure (PHLF)', 'timeFrame': 'Perioperative upto day 5', 'description': 'nuber of patients undergoing hepatice failure in both study arm after the major hepatectomies define by ndicated by elevated total bilirubin (\\\\(\\>22\\\\ \\\\mu \\\\text{mol/L}\\\\)) and increased INR (\\\\(\\>1.2\\\\)) on or after the fifth postoperative day (POD 5), as per ISGLS criteria'}, {'measure': 'Length of ICU stay', 'timeFrame': 'Perioperative upto day 30', 'description': 'number of days participant spent in ICU after hepatectomy till discharge in both treatment group'}, {'measure': 'Length of hospital stay,', 'timeFrame': 'Perioperative upto day 30', 'description': 'number of days participant spent in hospital after hepatectomy till discharge in both treatment group'}, {'measure': 'Incidence of 90 days mortality', 'timeFrame': 'Perioperative upto day 90', 'description': 'death of participant from any cause after the hepatecomy in both treatment groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunonutrition', 'Hepatectomy'], 'conditions': ['Hepatocellular Carcinoma', 'ASA I-III Patients']}, 'referencesModule': {'references': [{'pmid': '39764415', 'type': 'RESULT', 'citation': 'Zhang H, Li D, Li J. Prognostic significance of preoperative prognostic nutritional index in hepatocellular carcinoma after curative hepatectomy: a meta-analysis and systemic review. Front Nutr. 2024 Dec 23;11:1433528. doi: 10.3389/fnut.2024.1433528. eCollection 2024.'}, {'pmid': '33582497', 'type': 'RESULT', 'citation': 'Solanki SL, Kaur J, Gupta AM, Patkar S, Joshi R, Ambulkar RP, Patil A, Goel M. Cancer related nutritional and inflammatory markers as predictive parameters of immediate postoperative complications and long-term survival after hepatectomies. Surg Oncol. 2021 Jun;37:101526. doi: 10.1016/j.suronc.2021.101526. Epub 2021 Feb 4.'}, {'pmid': '29156839', 'type': 'RESULT', 'citation': 'Zhang C, Chen B, Jiao A, Li F, Wang B, Sun N, Zhang J. The benefit of immunonutrition in patients undergoing hepatectomy: a systematic review and meta-analysis. Oncotarget. 2017 Aug 8;8(49):86843-86852. doi: 10.18632/oncotarget.20045. eCollection 2017 Oct 17.'}, {'pmid': '33234742', 'type': 'RESULT', 'citation': 'Wong CS, Praseedom R, Liau SS. Perioperative immunonutrition in hepatectomy: A systematic review and meta-analysis. Ann Hepatobiliary Pancreat Surg. 2020 Nov 30;24(4):396-414. doi: 10.14701/ahbps.2020.24.4.396.'}, {'pmid': '33311018', 'type': 'RESULT', 'citation': 'Gao B, Luo J, Liu Y, Zhong F, Yang X, Gan Y, Su S, Li B. Clinical Efficacy of Perioperative Immunonutrition Containing Omega-3-Fatty Acids in Patients Undergoing Hepatectomy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ann Nutr Metab. 2020;76(6):375-386. doi: 10.1159/000509979. Epub 2020 Dec 11.'}, {'pmid': '37128515', 'type': 'RESULT', 'citation': 'Beevi Ss S, Pottakkat B. Effect of Immunonutrition on the Liver Function Status of End-Stage Liver Disease Patients Waiting/Referred for Liver Transplant: A Randomized Controlled Trial. Cureus. 2023 Mar 30;15(3):e36923. doi: 10.7759/cureus.36923. eCollection 2023 Mar.'}, {'pmid': '39550568', 'type': 'RESULT', 'citation': 'Zhang G, Zhao B, Deng T, He X, Chen Y, Zhong C, Chen J. Impact of perioperative immunonutrition on postoperative outcomes in pancreaticoduodenectomy: a systematic review and meta-analysis of randomized controlled trials. BMC Gastroenterol. 2024 Nov 16;24(1):412. doi: 10.1186/s12876-024-03510-6.'}, {'pmid': '39863958', 'type': 'RESULT', 'citation': "Markar S, Mariette C, Bonnetain F, Lundell L, Rosati R, de Manzoni G, Bonavina L, Tucker O, Plum P, D'Journo XB, Van Daele D, Cogill G, Santi S, Farran L, Iranzo V, Pera M, Veziant J, Piessen G. Immunonutrition to improve the quality of life of upper gastrointestinal cancer patients undergoing neoadjuvant treatment prior to surgery (NEOIMMUNE): double-blind randomized controlled multicenter clinical trial. Dis Esophagus. 2025 Jan 7;38(1):doae113. doi: 10.1093/dote/doae113."}, {'pmid': '30871811', 'type': 'RESULT', 'citation': 'Franken LC, Schreuder AM, Roos E, van Dieren S, Busch OR, Besselink MG, van Gulik TM. Morbidity and mortality after major liver resection in patients with perihilar cholangiocarcinoma: A systematic review and meta-analysis. Surgery. 2019 May;165(5):918-928. doi: 10.1016/j.surg.2019.01.010. Epub 2019 Mar 11.'}, {'pmid': '36577599', 'type': 'RESULT', 'citation': 'van Keulen AM, Buttner S, Erdmann JI, Hagendoorn J, Hoogwater FJH, IJzermans JNM, Neumann UP, Polak WG, De Jonge J, Olthof PB, Koerkamp BG. Major complications and mortality after resection of intrahepatic cholangiocarcinoma: A systematic review and meta-analysis. Surgery. 2023 Apr;173(4):973-982. doi: 10.1016/j.surg.2022.11.027. Epub 2022 Dec 27.'}]}, 'descriptionModule': {'briefSummary': 'A randomised open labelled study to evalaute the impact of immunonutrition in Patients Undergoing Hepatectomies for Liver Tumors', 'detailedDescription': 'Major hepatectomy remains a cornerstone in the curative management of primary and secondary liver tumors. Despite substantial advances in surgical techniques, anesthesia, and perioperative care, hepatectomy continues to be associated with considerable postoperative morbidity and mortality. Reported morbidity rates range from 22% to 40%, while mortality rates vary between 4% and 11%, largely driven by postoperative infectious complications, liver failure, and systemic inflammatory responses. Optimization of preoperative patient status, particularly nutritional and immune function, has therefore emerged as a critical area of interest to improve postoperative outcomes.\n\nImmunonutrition, defined as nutritional supplementation enriched with specific substrates such as arginine, omega-3 fatty acids, and nucleotides, has demonstrated beneficial effects in patients undergoing major gastrointestinal surgery, pancreatic resections, and liver transplantation. These formulations are thought to modulate immune response, attenuate postoperative inflammation, improve protein synthesis, and enhance wound healing. However, evidence supporting the routine use of immunonutrition in patients undergoing hepatectomy remains limited and inconsistent. Existing meta-analyses suggest reductions in postoperative infectious complications and length of hospital stay, but uncertainty persists regarding its overall clinical benefit, particularly in relation to objective nutritional and immunological markers.\n\nThe prognostic nutritional index (PNI), calculated using serum albumin levels and total lymphocyte count, is a validated composite marker reflecting both nutritional and immune status. Multiple studies and meta-analyses have shown that a higher preoperative PNI is associated with improved postoperative outcomes and survival following hepatectomy. Furthermore, recent evidence indicates that inflammatory and nutritional biomarkers, including dynamic changes in albumin-based indices, are strong predictors of postoperative morbidity. These findings suggest that targeted immunonutritional interventions capable of improving PNI may translate into meaningful clinical benefits.\n\nAgainst this background, the present study is designed to evaluate whether preoperative immunonutrition can improve PNI in patients undergoing major hepatectomy for liver tumors. The central hypothesis is that short-term preoperative immunonutrition leads to a measurable improvement in PNI compared with standard nutritional care.\n\nThe aim of the study is to assess the effect of preoperative immunonutrition on the prognostic nutritional index in patients planned for major hepatectomy.\n\nThe primary objective is to compare the mean change in PNI between patients receiving immunonutrition and those receiving standard nutritional care.\n\nSecondary objectives include evaluating the impact of immunonutrition on postoperative complications, incidence of post-hepatectomy liver failure, length of intensive care unit stay, overall hospital stay, and 90-day postoperative mortality.\n\nThis is an open-label, randomized, phase II controlled trial conducted at Tata Memorial Hospital, Mumbai. Adult patients (≥18 years) with liver tumors scheduled for major hepatectomy, defined as resection of three or more liver segments, and classified as ASA physical status I-III will be eligible for inclusion. Patients with severe renal dysfunction, hypersensitivity to immunonutritional components, inability to tolerate oral intake, pregnancy, or conditions impairing informed consent will be excluded.\n\nEligible patients providing written informed consent will be randomized in a 1:1 ratio into one of two study groups using a centrally generated permuted-block randomization sequence. The intervention group will receive preoperative immunonutrition in addition to their usual oral intake for seven consecutive days prior to surgery. The immunonutritional supplement will be administered in weight-adjusted doses and compliance will be monitored through patient records and telephonic reminders. The control group will continue with their usual oral intake; patients identified as malnourished in this group will receive standard nutritional supplementation as per institutional protocols.\n\nBlood samples will be collected at baseline and repeated on the day prior to surgery to assess serum albumin, lymphocyte count, and inflammatory markers. PNI will be calculated at baseline and preoperatively to evaluate the effect of the intervention. Postoperative assessments will include serial liver function tests, documentation of complications up to 90 days, and recording of ICU and hospital stay durations.\n\nA total of 100 patients (50 per group) will be enrolled over two years, providing adequate power to detect a clinically meaningful difference in PNI between groups. Data will be collected prospectively and analyzed using appropriate statistical methods. Continuous variables will be summarized using means and standard deviations, while categorical variables will be expressed as proportions. The primary endpoint will be analyzed by comparing mean PNI differences between groups, with secondary outcomes evaluated using standard comparative statistical tests.\n\nIn summary, this study seeks to generate high-quality prospective evidence on the role of preoperative immunonutrition in improving nutritional and immune status, as measured by PNI, in patients undergoing major hepatectomy. The findings have the potential to inform perioperative nutritional strategies and improve postoperative outcomes in this high-risk surgical population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with liver tumors planned for major hepatectomies (defined as resection of \\>/= 3 liver segments)\n2. Age above 18 years\n3. ASA class I-III\n\nExclusion Criteria:\n\n1. Preoperative severe renal failure (estimated glomerular filtration rate \\< 30 ml/min)\n2. History of hypersensitivity to arginine, omega-3 fatty acids, or nucleotide 3. Inability to take oral nutrition\n\n4\\. Pregnancy 5. Mental condition rendering the subject unable to understand the nature, endpoints and consequences of the trial'}, 'identificationModule': {'nctId': 'NCT07395635', 'briefTitle': 'Phase II Trial of Immunonutrition in Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tata Memorial Centre'}, 'officialTitle': 'Impact of Immunonutrition in Patients Undergoing Hepatectomies for Liver Tumors: A Randomized Controlled Phase II Trial', 'orgStudyIdInfo': {'id': 'Study no: 4783'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Immunomax® Powder- Participant in this group will receive Immunomac Powder 7 consecutive days preceding surgery in a dose of 6-9 scoops (120-180g per day), based on their bodyweight.', 'interventionNames': ['Dietary Supplement: Immunonutrition']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Arm', 'description': 'Participant in this group will be advised to continue with their usual oral intake. Patients in this group assessed as having malnutrition will be provided with a standard nutritional supplement (Fortisip®, Nutricia) twice daily (providing 600 kcal energy, 24 g protein), in addition to their usual intake, for the period preceding and including 7 days prior to surgery'}], 'interventions': [{'name': 'Immunonutrition', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['PENTASURE IMMUNOMAX POWDER'], 'description': 'In addition to their usual intake, patients in the intervention arm will be prescribed for each of the 7 consecutive days preceding surgery 6-9 scoops PENTASURE Immunomax® powder (120-180g per day)', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400012', 'city': 'Mumbai', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr. Shraddha Patkar, MD MCh', 'role': 'CONTACT', 'email': 'drshraddhapatkar@gmail.com', 'phone': '9820074818'}, {'name': 'Dr. Shraddha Patkar, MD MCh', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr. Mahesh Goel, MBBS, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dr. Sridhar Sundaram, MBBS, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dr. Shraddha Patkar', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], 'centralContacts': [{'name': 'Dr. Shraddha Patkar, MD MCh', 'role': 'CONTACT', 'email': 'drshraddhapatkar@gmail.com', 'phone': '9820074818'}, {'name': 'Dr Mahesh Goel, MBBS, MD', 'role': 'CONTACT', 'email': 'drmaheshgoel@gmail.com', 'phone': '9820504492'}], 'overallOfficials': [{'name': 'Dr. Shraddha Patkar, MD MCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor and surgeon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Memorial Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Surgeon', 'investigatorFullName': 'Dr Shraddha Patkar', 'investigatorAffiliation': 'Tata Memorial Centre'}}}}