Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-01-01 @ 5:10 AM
Study NCT ID:
NCT07085806
Status:
RECRUITING
Last Update Posted:
2025-07-25
First Post:
2025-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Study Effect of Injection Pentoxifylline on Liver Growth After Major Liver Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010431', 'term': 'Pentoxifylline'}, {'id': 'C048013', 'term': 'Plasmalyte A'}], 'ancestors': [{'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Control Trial- open label'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess effect of Pentoxifylline supplementation on Anatomical (Volume) Regeneration of liver in the Perioperative period (POD-14) in Right lobe donor Hepatectomy', 'timeFrame': '2 weeks post-operatively', 'description': 'Regenerated liver volume post-surgery Day-14 and Percentage of volume restored after Post surgery day 14 as compared to pre-operatively calculated Remnaant liver volume'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effect of Pentoxifylline on Serum Bilirubin- Time to Normalization', 'timeFrame': '2 weeks', 'description': 'Serum bilirubin on Post-operative Day 1 to 7 and 14'}, {'measure': 'To evaluate the effect on HGF', 'timeFrame': '1 week', 'description': 'HGF (Hepatocyte Growth Factor) levels on Baseline, Postoperative Day 3, and Day 7'}, {'measure': 'To study the effect of Pentoxifylline supplementation on post-operative complications in donor right hepatectomy', 'timeFrame': 'Postoperative Day 14', 'description': 'Clavien-Dindo Classification Grading on Post-operative Day 14'}, {'measure': 'Time to normalziation of Aspartate Transaminase', 'timeFrame': 'Post-operative Day 14', 'description': 'Aspartate transaminase (Baseline, Post-operative Day 1 to 7 and 14)'}, {'measure': 'Time to normalzation of Alanine transaminase', 'timeFrame': 'Post-operative Day 14', 'description': 'Alanine Transaminase on BASELINE, POST-OPERATIVE DAY 1 TO 7 and 14'}, {'measure': 'Time to Normalisation of International Normalized Ratio', 'timeFrame': 'Post-operative Day 14', 'description': 'International Normalized Ratio on Baseline Post-operative Day 1 to 7 and 14'}, {'measure': 'Time to normalisation of Serum Alkaline phosphatase', 'timeFrame': 'Post-operative Day 14', 'description': 'Serum Alkaline Phosphatase levels on Baseline, Post-operative Day 1 to 7 and 14'}, {'measure': 'Time to normalisation of Gamma-Glutamyl Transferase', 'timeFrame': 'Post-operative Day 14', 'description': 'Gamma-Glutamyl Transferase levels on baseline, Post-operative Day 1 to 7 and 14'}, {'measure': 'Effect on TNF-alpha (Tumor Necrosis Factor alpha)', 'timeFrame': 'Post-operative Day 7', 'description': 'TNF-alpha (Tumor Necrosis Factor alpha) levels on Baseline, Post-operative Day 3 and 7'}, {'measure': 'Effect on IL-6 (Interleukin-6)', 'timeFrame': 'Post-operative day 7', 'description': 'IL-6 levels on baseline , post-operative day 3 and 7'}, {'measure': 'Effect on TGF-beta (Transforming Growth Factor beta)', 'timeFrame': 'POst-operative Day 7', 'description': 'TGF-beta levels on Baseline, Post-operative Day 3 and 7'}, {'measure': 'Effect on AFP (Alpha-fetoprotein)', 'timeFrame': 'Post-operative day 7', 'description': 'AFP (Alpha-fetoprotein) levels on Baseline, post-operative Day 3 and Day 7'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Role of Injection pentoxifylline in Liver regeneration after Right lobe Hepatectomy'], 'conditions': ['Liver Regeneration']}, 'referencesModule': {'references': [{'pmid': '16537374', 'type': 'RESULT', 'citation': 'Tian Y, Jochum W, Georgiev P, Moritz W, Graf R, Clavien PA. Kupffer cell-dependent TNF-alpha signaling mediates injury in the arterialized small-for-size liver transplantation in the mouse. Proc Natl Acad Sci U S A. 2006 Mar 21;103(12):4598-603. doi: 10.1073/pnas.0600499103. Epub 2006 Mar 13.'}, {'pmid': '22816029', 'type': 'RESULT', 'citation': "Martino RB, Coelho AM, Kubrusly MS, Leitao R, Sampietre SN, Machado MC, Bacchella T, D'Albuquerque LA. Pentoxifylline improves liver regeneration through down-regulation of TNF-alpha synthesis and TGF-beta1 gene expression. World J Gastrointest Surg. 2012 Jun 27;4(6):146-51. doi: 10.4240/wjgs.v4.i6.146."}, {'pmid': '21037437', 'type': 'RESULT', 'citation': 'Petrowsky H, Breitenstein S, Slankamenac K, Vetter D, Lehmann K, Heinrich S, DeOliveira ML, Jochum W, Weishaupt D, Frauenfelder T, Graf R, Clavien PA. Effects of pentoxifylline on liver regeneration: a double-blinded, randomized, controlled trial in 101 patients undergoing major liver resection. Ann Surg. 2010 Nov;252(5):813-22. doi: 10.1097/SLA.0b013e3181fcbc5e.'}]}, 'descriptionModule': {'briefSummary': 'Posthepatectomy liver failure (PHLF) remains a significant life-threatening problem after major hepatectomies. Pentoxifylline is shown to have potent vasodilating properties for peripheral blood vessels, along with the hepatic vasculature. In a Double-blinded, randomized, controlled trial (RCT) at a single tertiary care center (2006-2009) by Petrowsky, Henrik et al (Annals of Surgery, November 2010) on 101 Non-cirrhotic patients undergoing major Hepatectomy, they demonstrated beneficial effects of Pentoxifylline on regeneration of small remnant livers (RLBW ratio ≤ 1.2%). In mice model, pentoxifylline (Tian, Yinghua, et al Proceedings of the National Academy of Sciences 103.12 (2006)) is shown to confer protective effects against small-for-size syndrome in arterialized small-for-size liver transplantation. This Randomised control trial is being conducted to analyze the effect of Pentoxifylline supplementation in live donors undergoing donor hepatectomy with respect to markers of anatomical regeneration in a high volume liver transplant center in India.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All live donors undergoing Right Donor Hepatectomy after ethical board clearance in the Department of HPB Surgery and Liver Transplantation\n\nExclusion Criteria:\n\n* Negative consent Hypersensitivity to Pentoxifylline'}, 'identificationModule': {'nctId': 'NCT07085806', 'briefTitle': 'To Study Effect of Injection Pentoxifylline on Liver Growth After Major Liver Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Effect of Pentoxifylline on Liver Regeneration After Right Lobe Donor Hepatectomy: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'IEC/2024/110/MA01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plasmalyte', 'description': 'Intravenous fluid plasmalyte.', 'interventionNames': ['Other: Plasmalyte']}, {'type': 'EXPERIMENTAL', 'label': 'Pentoxifylline group', 'description': 'Intravenous injection Pentoxifylline', 'interventionNames': ['Drug: Pentoxifylline (also known as oxpentifylline)']}], 'interventions': [{'name': 'Pentoxifylline (also known as oxpentifylline)', 'type': 'DRUG', 'description': 'Intravenous injection Pentoxifylline 1 mg/kg/hr dissolved in Plasma Lyte/0.9% Normal saline from12 hours before the surgery to 72 hours after the Surgery', 'armGroupLabels': ['Pentoxifylline group']}, {'name': 'Plasmalyte', 'type': 'OTHER', 'description': 'Plasmalyte', 'armGroupLabels': ['Plasmalyte']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Parneet Dr', 'role': 'CONTACT', 'email': 'parneet.sunam@gmail.com', 'phone': '+917888524159'}, {'name': 'Nilesh S Patil, MBBS, MS, M Ch', 'role': 'CONTACT', 'email': 'dr.nils.p@gmail.com', 'phone': '+919540947478'}], 'facility': 'Institute of Liver and Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'Parneet Dr', 'role': 'CONTACT', 'email': 'parneet.sunam@gmail.com', 'phone': '+917888524169'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}