| CTRI Number |
CTRI/2025/08/092444 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A First Look at How Lymphatic System Issues May Cause Persistent Fluid retention in the abdomen of the recipient After a Liver Transplant |
|
Scientific Title of Study
|
Correlation between Persistent Post Liver Transplantation Ascites and Lymphatic
Molecular Dysfunction: A Pilot study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veluru Gautham |
| Designation |
Senior Resident |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Department of HPB Surgery and liver transplantation, INSTITUTE OF LIVER AND BILIARY SCIENCES, D-1, VASANT KUNJ, NEW DELHI.
South DELHI 110070 India |
| Phone |
9440346072 |
| Fax |
|
| Email |
veluru.gautham2@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Viniyendra Pamecha |
| Designation |
Professor and Head of the department |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Department of HPB Surgery and liver transplant,INSTITUTE OF LIVER AND BILIARY SCIENCES, D-1, VASANT KUNJ, NEW DELHI.
South DELHI 110070 India |
| Phone |
9440346072 |
| Fax |
|
| Email |
viniyendra@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Veluru Gautham |
| Designation |
Senior Resident |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Department of HPB surgery and liver transplant, INSTITUTE OF LIVER AND BILIARY SCIENCES, D-1, VASANT KUNJ, NEW DELHI.
South DELHI 110070 India |
| Phone |
9440346072 |
| Fax |
|
| Email |
veluru.gautham2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
D-1, Vasant Kunj, New Delhi.
PIN: 110070 |
| 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 |
| Dr Veluru Gautham |
Institute of Liver and Biliary Sciences |
Institute of liver and biliary sciences, Vasant Kunj, New Delhi, PIN: 110070
South West
DELHI South DELHI |
9440346072
veluru.gautham2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC)/ Institutional review Board (IRB), Institute of Liver and Biliary sciences. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K720||Acute and subacute hepatic failure, (2) ICD-10 Condition: K703||Alcoholic cirrhosis of liver, (3) ICD-10 Condition: K754||Autoimmune hepatitis, (4) ICD-10 Condition: K766||Portal hypertension, (5) ICD-10 Condition: K743||Primary biliary cirrhosis, (6) ICD-10 Condition: K744||Secondary biliary cirrhosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All prospective recipients who underwent LDLT in the Department of HPB Surgery and Liver Transplantation, Institute of Liver and Biliary Sciences.
|
|
| ExclusionCriteria |
| Details |
Negative consent, Acute liver failure, DDLT
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the degree of lymphatic dysfunction and its correlation with persistent post liver transplant ascites. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
RNA isolation & RT-PCR analysis of specific genes (Identity markers- PDPN, LYVE1, CD31).
To identify the perioperative risk factors & postoperative sequelae of lymphatic dysfunction. |
on the day of surgery, postoperative day 3, 7, 14 |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Ascites is the most common sign of decompensated cirrhosis, developing in about 5–10% of patients with compensated cirrhosis each year. Liver transplantation (LT) remains the most effective treatment for such patients, as it corrects the underlying circulatory and kidney dysfunction, leading to resolution of ascites in most cases. However, it is common to see small to moderate ascites during the early postoperative period after LT, typically resolving within 2 to 4 weeks. When ascites persists beyond 4 weeks after transplantation—referred to as persistent ascites (PA)—it occurs in up to 7% of patients. Although relatively uncommon, PA is linked with worse clinical outcomes, including increased complications and reduced 1-year survival. Animal studies, particularly in mice, have suggested that lymphatic system dysfunction may contribute to the formation of ascites. Therefore, this study aims to evaluate whether there is a correlation between lymphatic dysfunction and persistent ascites following liver transplantation. |