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

Not Applicable

Recruiting

• Conditions: Liver Regeneration
• Interventions: Other: Plasmalyte; Drug: Pentoxifylline (also known as oxpentifylline)

• Registration Number: NCT07085806
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-29
• Primary Completion: 2025-07-15
• Study First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasmalyte	Plasmalyte	Intravenous fluid plasmalyte.
Pentoxifylline group	Pentoxifylline (also known as oxpentifylline)	Intravenous injection Pentoxifylline

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Time to normalziation of Aspartate Transaminase	Post-operative Day 14	Aspartate transaminase (Baseline, Post-operative Day 1 to 7 and 14)
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
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 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
Effect on AFP (Alpha-fetoprotein)	Post-operative day 7	AFP (Alpha-fetoprotein) levels on Baseline, post-operative Day 3 and Day 7

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, India