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

NCT ID: NCT07085806

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Liver Regeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Control Trial- open label
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Plasmalyte

Intravenous fluid plasmalyte.

Group Type ACTIVE_COMPARATOR

Plasmalyte

Intervention Type OTHER

Plasmalyte

Pentoxifylline group

Intravenous injection Pentoxifylline

Group Type EXPERIMENTAL

Pentoxifylline (also known as oxpentifylline)

Intervention Type 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

Interventions

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Pentoxifylline (also known as oxpentifylline)

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

Intervention Type DRUG

Plasmalyte

Plasmalyte

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Liver and Biliary Sciences

New Delhi, , India

Site Status RECRUITING

Countries

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India

Central Contacts

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Parneet Dr

Role: CONTACT

+917888524169

Facility Contacts

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Parneet Dr

Role: primary

+917888524159

Nilesh S Patil, MBBS, MS, M Ch

Role: backup

+919540947478

References

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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.

Reference Type RESULT
PMID: 16537374 (View on PubMed)

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.

Reference Type RESULT
PMID: 22816029 (View on PubMed)

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.

Reference Type RESULT
PMID: 21037437 (View on PubMed)

Other Identifiers

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IEC/2024/110/MA01

Identifier Type: -

Identifier Source: org_study_id

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