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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorInstitute of Liver and Biliary Sciences, India

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Plasmalyte

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: PlasmalyteActive comparator 1 intervention
Group B: Pentoxifylline groupExperimental treatment 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

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
2

To evaluate the effect on HGF

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

Time frame
1 week
3

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
4

Time to normalziation of Aspartate Transaminase

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

Time frame
Post-operative Day 14

Other outcomes

Sponsors and contacts

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