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NCT Number: NCT07085806

To Study Effect of Injection Pentoxifylline on Liver Growth After Major Liver Surgery

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.

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Key information

Conditions

Liver Regeneration

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pentoxifylline (also known as oxpentifylline)

Drug

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

Other

Plasmalyte

Primary outcomes

  1. 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

    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

  1. To evaluate the effect of Pentoxifylline on Serum Bilirubin- Time to Normalization

    Time frame: 2 weeks

    Serum bilirubin on Post-operative Day 1 to 7 and 14

  2. To evaluate the effect on HGF

    Time frame: 1 week

    HGF (Hepatocyte Growth Factor) levels on Baseline, Postoperative Day 3, and Day 7

  3. To study the effect of Pentoxifylline supplementation on post-operative complications in donor right hepatectomy

    Time frame: Postoperative Day 14

    Clavien-Dindo Classification Grading on Post-operative Day 14

  4. Time to normalziation of Aspartate Transaminase

    Time frame: Post-operative Day 14

    Aspartate transaminase (Baseline, Post-operative Day 1 to 7 and 14)

  5. Time to normalzation of Alanine transaminase

    Time frame: Post-operative Day 14

    Alanine Transaminase on BASELINE, POST-OPERATIVE DAY 1 TO 7 and 14

  6. Time to Normalisation of International Normalized Ratio

    Time frame: Post-operative Day 14

    International Normalized Ratio on Baseline Post-operative Day 1 to 7 and 14

  7. Time to normalisation of Serum Alkaline phosphatase

    Time frame: Post-operative Day 14

    Serum Alkaline Phosphatase levels on Baseline, Post-operative Day 1 to 7 and 14

  8. Time to normalisation of Gamma-Glutamyl Transferase

    Time frame: Post-operative Day 14

    Gamma-Glutamyl Transferase levels on baseline, Post-operative Day 1 to 7 and 14

  9. Effect on TNF-alpha (Tumor Necrosis Factor alpha)

    Time frame: Post-operative Day 7

    TNF-alpha (Tumor Necrosis Factor alpha) levels on Baseline, Post-operative Day 3 and 7

  10. Effect on IL-6 (Interleukin-6)

    Time frame: Post-operative day 7

    IL-6 levels on baseline , post-operative day 3 and 7

  11. Effect on TGF-beta (Transforming Growth Factor beta)

    Time frame: POst-operative Day 7

    TGF-beta levels on Baseline, Post-operative Day 3 and 7

  12. Effect on AFP (Alpha-fetoprotein)

    Time frame: Post-operative day 7

    AFP (Alpha-fetoprotein) levels on Baseline, post-operative Day 3 and Day 7

Study contacts

Contact information is provided by the study sponsor or research team.

Parneet Dr

CONTACT

[email protected]

+917888524169

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

Effect of Pentoxifylline on Liver Regeneration After Right Lobe Donor Hepatectomy: A Randomized Control Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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