About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All live donors undergoing Right Donor Hepatectomy after ethical board clearance in the Department of HPB Surgery and Liver Transplantation
Disqualifiers
Negative consent Hypersensitivity to Pentoxifylline
Trial design
Parallel
Treatments tested in this trial
Pentoxifylline (also known as oxpentifylline)
DrugIntravenous 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
Plasmalyte
Other interventionPlasmalyte
Treatment groups
Trial outcomes
Primary outcomes
To assess effect of Pentoxifylline supplementation on Anatomical (Volume) Regeneration of liver in the Perioperative period (POD-14) in Right lobe donor Hepatectomy
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
Secondary outcomes
To evaluate the effect of Pentoxifylline on Serum Bilirubin- Time to Normalization
Serum bilirubin on Post-operative Day 1 to 7 and 14
To evaluate the effect on HGF
HGF (Hepatocyte Growth Factor) levels on Baseline, Postoperative Day 3, and Day 7
To study the effect of Pentoxifylline supplementation on post-operative complications in donor right hepatectomy
Clavien-Dindo Classification Grading on Post-operative Day 14
Time to normalziation of Aspartate Transaminase
Aspartate transaminase (Baseline, Post-operative Day 1 to 7 and 14)
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