Liver Regeneration
Conditions
Keywords
Role of Injection pentoxifylline in Liver regeneration after Right lobe Hepatectomy
Brief summary
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
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
OTHERPlasmalyte
Plasmalyte
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomised Control Trial- open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess effect of Pentoxifylline supplementation on Anatomical (Volume) Regeneration of liver in the Perioperative period (POD-14) in Right lobe donor Hepatectomy | 2 weeks post-operatively | 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
| Measure | Time frame | Description |
|---|---|---|
| Effect on AFP (Alpha-fetoprotein) | Post-operative day 7 | AFP (Alpha-fetoprotein) levels on Baseline, post-operative Day 3 and Day 7 |
| Effect on IL-6 (Interleukin-6) | Post-operative day 7 | IL-6 levels on baseline , post-operative day 3 and 7 |
| To evaluate the effect of Pentoxifylline on Serum Bilirubin- Time to Normalization | 2 weeks | Serum bilirubin on Post-operative Day 1 to 7 and 14 |
| To evaluate the effect on HGF | 1 week | 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 | Postoperative Day 14 | Clavien-Dindo Classification Grading on Post-operative Day 14 |
| Effect on TGF-beta (Transforming Growth Factor beta) | POst-operative Day 7 | TGF-beta levels on Baseline, Post-operative Day 3 and 7 |
| Time to normalzation of Alanine transaminase | Post-operative Day 14 | Alanine Transaminase on BASELINE, POST-OPERATIVE DAY 1 TO 7 and 14 |
| Time to Normalisation of International Normalized Ratio | Post-operative Day 14 | International Normalized Ratio on Baseline Post-operative Day 1 to 7 and 14 |
| Time to normalisation of Serum Alkaline phosphatase | Post-operative Day 14 | Serum Alkaline Phosphatase levels on Baseline, Post-operative Day 1 to 7 and 14 |
| Time to normalisation of Gamma-Glutamyl Transferase | Post-operative Day 14 | Gamma-Glutamyl Transferase levels on baseline, Post-operative Day 1 to 7 and 14 |
| Effect on TNF-alpha (Tumor Necrosis Factor alpha) | Post-operative Day 7 | TNF-alpha (Tumor Necrosis Factor alpha) levels on Baseline, Post-operative Day 3 and 7 |
| Time to normalziation of Aspartate Transaminase | Post-operative Day 14 | Aspartate transaminase (Baseline, Post-operative Day 1 to 7 and 14) |
Countries
India
Contacts
Primary ContactParneet Dr
Outcome results
None listed