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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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