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

NCT07085806 | Recruiting

• 1 other identifier: IEC/2024/110/MA01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Regeneration

Keywords

Role of Injection pentoxifylline in Liver regeneration after Right lobe Hepatectomy

Outcome Measures

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

  2 weeks post-operatively

Secondary Outcomes (12)

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

  2 weeks

• To evaluate the effect on HGF

  1 week

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

  Postoperative Day 14

• Time to normalziation of Aspartate Transaminase

  Post-operative Day 14

• Time to normalzation of Alanine transaminase

  Post-operative Day 14

Study Arms (2)

Plasmalyte

ACTIVE COMPARATOR

Intravenous fluid plasmalyte.

Other: Plasmalyte

Pentoxifylline group

EXPERIMENTAL

Intravenous injection Pentoxifylline

Drug: Pentoxifylline (also known as oxpentifylline)

Interventions

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

Pentoxifylline group

Plasmalyte OTHER

Plasmalyte

Plasmalyte

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All live donors undergoing Right Donor Hepatectomy after ethical board clearance in the Department of HPB Surgery and Liver Transplantation

You may not qualify if:

• Negative consent Hypersensitivity to Pentoxifylline

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, 110070, India

RECRUITING

Related Publications (3)

• Tian Y, Jochum W, Georgiev P, Moritz W, Graf R, Clavien PA. Kupffer cell-dependent TNF-alpha signaling mediates injury in the arterialized small-for-size liver transplantation in the mouse. Proc Natl Acad Sci U S A. 2006 Mar 21;103(12):4598-603. doi: 10.1073/pnas.0600499103. Epub 2006 Mar 13.

  PMID: 16537374 RESULT

• Martino RB, Coelho AM, Kubrusly MS, Leitao R, Sampietre SN, Machado MC, Bacchella T, D'Albuquerque LA. Pentoxifylline improves liver regeneration through down-regulation of TNF-alpha synthesis and TGF-beta1 gene expression. World J Gastrointest Surg. 2012 Jun 27;4(6):146-51. doi: 10.4240/wjgs.v4.i6.146.

  PMID: 22816029 RESULT

• Petrowsky H, Breitenstein S, Slankamenac K, Vetter D, Lehmann K, Heinrich S, DeOliveira ML, Jochum W, Weishaupt D, Frauenfelder T, Graf R, Clavien PA. Effects of pentoxifylline on liver regeneration: a double-blinded, randomized, controlled trial in 101 patients undergoing major liver resection. Ann Surg. 2010 Nov;252(5):813-22. doi: 10.1097/SLA.0b013e3181fcbc5e.

  PMID: 21037437 RESULT

MeSH Terms

Interventions

Pentoxifylline; Plasmalyte A

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Parneet Dr

CONTACT

+917888524169; parneet.sunam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Control Trial- open label

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: July 25, 2025
• Study Start: January 1, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 31, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)