To Study Effect of Injection Pentoxifylline on Liver Growth After Major Liver Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pentoxifylline (also known as oxpentifylline), Plasmalyte.
- Who it may be relevant to
- Registry conditions: Liver Regeneration. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Pentoxifylline on Liver Regeneration After Right Lobe Donor Hepatectomy: A Randomized Control Trial
Overview
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.
Interventions
- Drug Pentoxifylline (also known as oxpentifylline)
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 - Other Plasmalyte
Plasmalyte
Primary outcome measures
- To assess effect of Pentoxifylline supplementation on Anatomical (Volume) Regeneration of liver in the Perioperative period (POD-14) in Right lobe donor Hepatectomy [Time frame: 2 weeks post-operatively]
Secondary outcome measures (12)
- To evaluate the effect of Pentoxifylline on Serum Bilirubin- Time to Normalization [Time frame: 2 weeks]
- To evaluate the effect on HGF [Time frame: 1 week]
- To study the effect of Pentoxifylline supplementation on post-operative complications in donor right hepatectomy [Time frame: Postoperative Day 14]
- Time to normalziation of Aspartate Transaminase [Time frame: Post-operative Day 14]
- Time to normalzation of Alanine transaminase [Time frame: Post-operative Day 14]
- Time to Normalisation of International Normalized Ratio [Time frame: Post-operative Day 14]
- Time to normalisation of Serum Alkaline phosphatase [Time frame: Post-operative Day 14]
- Time to normalisation of Gamma-Glutamyl Transferase [Time frame: Post-operative Day 14]
- Effect on TNF-alpha (Tumor Necrosis Factor alpha) [Time frame: Post-operative Day 7]
- Effect on IL-6 (Interleukin-6) [Time frame: Post-operative day 7]
- Effect on TGF-beta (Transforming Growth Factor beta) [Time frame: POst-operative Day 7]
- Effect on AFP (Alpha-fetoprotein) [Time frame: Post-operative day 7]
Eligibility criteria
Inclusion criteria
- All live donors undergoing Right Donor Hepatectomy after ethical board clearance in the Department of HPB Surgery and Liver Transplantation
Exclusion criteria
- Negative consent Hypersensitivity to Pentoxifylline
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
India · 1 center
- Institute of Liver and Biliary Sciences — New Delhi
Publications
- 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 16537374
- 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 22816029
- 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. PMID 21037437
Identifiers
NCT: NCT07085806 · IEC/2024/110/MA01