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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
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
Plasmalyte
Institute of Liver and Biliary Sciences
New Delhi, India
RECRUITINGTo 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
Time frame: 2 weeks post-operatively
To evaluate the effect of Pentoxifylline on Serum Bilirubin- Time to Normalization
Serum bilirubin on Post-operative Day 1 to 7 and 14
Time frame: 2 weeks
To evaluate the effect on HGF
HGF (Hepatocyte Growth Factor) levels on Baseline, Postoperative Day 3, and Day 7
Time frame: 1 week
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 frame: Postoperative Day 14
Time to normalziation of Aspartate Transaminase
Aspartate transaminase (Baseline, Post-operative Day 1 to 7 and 14)
Time frame: Post-operative Day 14
Time to normalzation of Alanine transaminase
Alanine Transaminase on BASELINE, POST-OPERATIVE DAY 1 TO 7 and 14
Time frame: Post-operative Day 14
Time to Normalisation of International Normalized Ratio
International Normalized Ratio on Baseline Post-operative Day 1 to 7 and 14
Time frame: Post-operative Day 14
Time to normalisation of Serum Alkaline phosphatase
Serum Alkaline Phosphatase levels on Baseline, Post-operative Day 1 to 7 and 14
Time frame: Post-operative Day 14
Time to normalisation of Gamma-Glutamyl Transferase
Gamma-Glutamyl Transferase levels on baseline, Post-operative Day 1 to 7 and 14
Time frame: Post-operative Day 14
Effect on TNF-alpha (Tumor Necrosis Factor alpha)
TNF-alpha (Tumor Necrosis Factor alpha) levels on Baseline, Post-operative Day 3 and 7
Time frame: Post-operative Day 7
Effect on IL-6 (Interleukin-6)
IL-6 levels on baseline , post-operative day 3 and 7
Time frame: Post-operative day 7
Effect on TGF-beta (Transforming Growth Factor beta)
TGF-beta levels on Baseline, Post-operative Day 3 and 7
Time frame: POst-operative Day 7
Effect on AFP (Alpha-fetoprotein)
AFP (Alpha-fetoprotein) levels on Baseline, post-operative Day 3 and Day 7
Time frame: Post-operative day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.