| CTRI Number |
CTRI/2025/06/089632 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Injection Pentoxifylline on Liver Regrowth in the Liver Donor after Right Side Liver Removal for Liver Donor surgery for living donor Liver Transplant |
|
Scientific Title of Study
|
Effect of Pentoxifylline on Liver Regeneration after Right Lobe Donor Hepatectomy A Randomized control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/2024/110/MA01 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parneet |
| Designation |
Senior Resident |
| Affiliation |
Institute of liver and Biliary Sciences, New Delhi |
| Address |
Department of HPB Surgery and Liver Transplant, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
7888524159 |
| Fax |
|
| Email |
parneet.sunam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh S. Patil |
| Designation |
Associate Professor |
| Affiliation |
Institute of liver and Biliary Sciences, New Delhi |
| Address |
Department of HPB Surgery and Liver Transplant, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
|
| Fax |
|
| Email |
dr.nils.p@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parneet |
| Designation |
Senior Resident |
| Affiliation |
Institute of liver and Biliary Sciences, New Delhi |
| Address |
Department of HPB Surgery and Liver Transplant, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
7888524159 |
| Fax |
|
| Email |
parneet.sunam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Parneet |
Institute of liver and biliary Sciences |
Department of HPB Surgery and Liver Transplantation
South West
DELHI |
7888524159
parneet.sunam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z526||Liver donor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Pentoxifylline |
Intravenous Pentoxifylline 1 mg/kg/hr dissolved in Plasma Lyte 12 hours before to 72 hours after Surgery |
| Comparator Agent |
Intravenous Fluid (PLasmalyte/ Normal Saline) |
Intravenous Fluid (PLasmalyte/ Normal Saline) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
All Voluntary Healthy Liver Donors undergoing Right Lobe Donor Hepatectomy |
|
| ExclusionCriteria |
| Details |
Negative consent
Hypersensitivity to pentoxifylline |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess effect of Pentoxifylline supplementation on Anatomical (Volume) Regeneration of liver in the Perioperative period (POD-14) in Right lobe donor Hepatectomy |
On Post-operative Day-14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Pentoxifylline on Liver function Tests- Time to Normalization |
Baseline, POD- 1 to 7 and POD 14 |
| To evaluate the effect of Pentoxifylline on biomarkers of liver regeneration (HGF, TNF-alpha, IL-6, TGF Beta, AFP) |
Baseline, POD-3 and POD-7 |
| To study the effect of Pentoxifylline supplementation on post-operative complications in donor right hepatectomy |
Discharge from hospital |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
06/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 less than 1.2 percent). 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. |