Liver RegenerationNCT07085806
To Study Effect of Injection Pentoxifylline on Liver Growth After Major Liver Surgery
A study testing Pentoxifylline (also known as oxpentifylline) and Plasmalyte in people with Liver Regeneration, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Liver Regeneration
- What is being tested?
- Pentoxifylline (also known as oxpentifylline) and Plasmalyte
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All live donors undergoing Right Donor Hepatectomy after ethical board clearance in the Department of HPB Surgery and Liver Transplantation
Who cannot join
- Negative consent Hypersensitivity to Pentoxifylline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Institute of Liver and Biliary Sciences
New Delhi, 110070
Parneet Dr, +917888524159, parneet.sunam@gmail.com
Nilesh S Patil, MBBS, MS, M Ch, +919540947478, dr.nils.p@gmail.com
About this study
Official title: Effect of Pentoxifylline on Liver Regeneration After Right Lobe Donor Hepatectomy: A Randomized Control 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.
- Conditions
- Liver Regeneration
- Being tested
- Pentoxifylline (also known as oxpentifylline), Plasmalyte
- Keywords
- Role of Injection pentoxifylline in Liver regeneration after Right lobe Hepatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlasmalyteOther
Plasmalyte
| Study group | Role | What they receive |
|---|---|---|
| Plasmalyte | Active comparator | Intravenous fluid plasmalyte. Receives: Other: Plasmalyte |
| Pentoxifylline group | Experimental | Intravenous injection Pentoxifylline Receives: Drug: Pentoxifylline (also known as oxpentifylline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks post-operatively
Secondary outcomes (12)
To evaluate the effect of Pentoxifylline on Serum Bilirubin- Time to Normalization
Serum bilirubin on Post-operative Day 1 to 7 and 14
Measured: 2 weeks
To evaluate the effect on HGF
HGF (Hepatocyte Growth Factor) levels on Baseline, Postoperative Day 3, and Day 7
Measured: 1 week
To study the effect of Pentoxifylline supplementation on post-operative complications in donor right hepatectomy
Clavien-Dindo Classification Grading on Post-operative Day 14
Measured: Postoperative Day 14
Time to normalziation of Aspartate Transaminase
Aspartate transaminase (Baseline, Post-operative Day 1 to 7 and 14)
Measured: Post-operative Day 14
Time to normalzation of Alanine transaminase
Alanine Transaminase on BASELINE, POST-OPERATIVE DAY 1 TO 7 and 14
Measured: Post-operative Day 14
Time to Normalisation of International Normalized Ratio
International Normalized Ratio on Baseline Post-operative Day 1 to 7 and 14
Measured: Post-operative Day 14
Time to normalisation of Serum Alkaline phosphatase
Serum Alkaline Phosphatase levels on Baseline, Post-operative Day 1 to 7 and 14
Measured: Post-operative Day 14
Time to normalisation of Gamma-Glutamyl Transferase
Gamma-Glutamyl Transferase levels on baseline, Post-operative Day 1 to 7 and 14
Measured: Post-operative Day 14
Effect on TNF-alpha (Tumor Necrosis Factor alpha)
TNF-alpha (Tumor Necrosis Factor alpha) levels on Baseline, Post-operative Day 3 and 7
Measured: Post-operative Day 7
Effect on IL-6 (Interleukin-6)
IL-6 levels on baseline , post-operative day 3 and 7
Measured: Post-operative day 7
Effect on TGF-beta (Transforming Growth Factor beta)
TGF-beta levels on Baseline, Post-operative Day 3 and 7
Measured: POst-operative Day 7
Effect on AFP (Alpha-fetoprotein)
AFP (Alpha-fetoprotein) levels on Baseline, post-operative Day 3 and Day 7
Measured: Post-operative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Jan 2025
- Primary completion15 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver RegenerationStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Control Trial- open label
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085806
- Sponsor's protocol ID
- IEC/2024/110/MA01
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16537374Martino 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.
PubMed 22816029Petrowsky 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.
PubMed 21037437
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pentoxifylline on Liver Regeneration After Right Lobe Donor Hepatectomy: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07085806
- Acronym / sponsor ID
- IEC/2024/110/MA01
- Conditions
- Liver Regeneration
- Keywords
- Role of Injection pentoxifylline in Liver regeneration after Right lobe Hepatectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Control Trial- open label
| Arm | Type | Receives |
|---|---|---|
| Plasmalyte | Active comparator | Other: PlasmalyteIntravenous fluid plasmalyte. |
| Pentoxifylline group | Experimental | Drug: Pentoxifylline (also known as oxpentifylline)Intravenous injection Pentoxifylline |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All live donors undergoing Right Donor Hepatectomy after ethical board clearance in the Department of HPB Surgery and Liver Transplantation
Key exclusion criteria (1 listed)
- Negative consent Hypersensitivity to Pentoxifylline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Pentoxifylline group |
| PlasmalytePlasmalyte | Other | Plasmalyte |
Primary outcome
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
12 secondary outcomes
To evaluate the effect of Pentoxifylline on Serum Bilirubin- Time to Normalization
Time frame: 2 weeks
To evaluate the effect on HGF
Time frame: 1 week
To study the effect of Pentoxifylline supplementation on post-operative complications in donor right hepatectomy
Time frame: Postoperative Day 14
Time to normalziation of Aspartate Transaminase
Time frame: Post-operative Day 14
Time to normalzation of Alanine transaminase
Time frame: Post-operative Day 14
Time to Normalisation of International Normalized Ratio
Time frame: Post-operative Day 14
Time to normalisation of Serum Alkaline phosphatase
Time frame: Post-operative Day 14
Time to normalisation of Gamma-Glutamyl Transferase
Time frame: Post-operative Day 14
Effect on TNF-alpha (Tumor Necrosis Factor alpha)
Time frame: Post-operative Day 7
Effect on IL-6 (Interleukin-6)
Time frame: Post-operative day 7
Effect on TGF-beta (Transforming Growth Factor beta)
Time frame: POst-operative Day 7
Effect on AFP (Alpha-fetoprotein)
Time frame: Post-operative day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Results publication: PubMed 16537374Tian 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.
- Results publication: PubMed 22816029Martino 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.
- Results publication: PubMed 21037437Petrowsky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentoxifylline (also known as oxpentifylline) and Plasmalyte in people with Liver Regeneration, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Parneet Dr (+917888524169, parneet.sunam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07085806, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.