| CTRI Number |
CTRI/2025/12/098718 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Artery and Veins of Liver by Transesophageal Echocardiography (TEE) in Living Donor Liver Recipients |
|
Scientific Title of Study
|
Evaluation of Hepatic Vasculature by Transesophageal Echocardiography (TEE) in Patients Undergoing Living Donor Liver Transplantation: A Prospective Observational 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 |
Abhishek Arya |
| Designation |
Senior Resident |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesia and Critical Care,
ILBS,
D-1, Vasant Kunj Rd, Ghitorni, New Delhi - 110070
South
DELHI
110070
India |
| Phone |
9013464755 |
| Fax |
|
| Email |
drarya.abhishek95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Sindwani |
| Designation |
Additional Professor and Head |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesia and Critical Care
ILBS,
D-1, Vasant Kunj Rd, Ghitorni, New Delhi - 110070
South
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Arya |
| Designation |
Senior Resident |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesia and Critical Care,
ILBS,
D-1, Vasant Kunj Rd, Ghitorni, New Delhi - 110070
South
DELHI
110070
India |
| Phone |
9013464755 |
| Fax |
|
| Email |
arya.abhishek95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesia and Critical Care,
ILBS, D-1, Vasant Kunj Rd, Ghitorni, New Delhi - 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 Abhishek Arya |
Institute of Liver and Biliary Sciences |
HPB Surgery OT Complex, 4th Floor, Phase-1,
ILBS, D-1, Vasant Kunj Rd, Ghitorni, New Delhi - 110070
South
DELHI |
9013464755
drarya.abhishek95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee / Institutional Review Board ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K703||Alcoholic cirrhosis of liver, (2) ICD-10 Condition: K739||Chronic hepatitis, unspecified, (3) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patents undergoing living donor liver transplantation |
|
| ExclusionCriteria |
| Details |
Patients having contraindications to TEE placement:
High risk esophageal varices,
Esophageal varices grade more than 2,
History of recent upper abdominal bleed within 1 month,
History of recent variceal ligation within 1 month,
Gastric antral variceal ectasia,
Gastric polyp,
Coagulopathy,
Esophageal strictures,
Esophageal tumor, and
Esophageal diverticula,
History of esophageal surgery,
Esophagitis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate portal vein, hepatic vein and hepatic artery velocity by TEE in patients undergoing living donor liver transplantation. |
Baseline,
After portal vein reperfusion,
After hepatic artery reperfusion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate portal vein flow by TEE in patients undergoing living donor liver transplantation. |
Baseline,
After portal vein reperfusion,
After hepatic artery reperfusion |
| To compare the portal vein, hepatic vein and hepatic artery velocity and waveform between TEE and intraoperative doppler. |
Baseline,
After portal vein reperfusion,
After hepatic artery reperfusion |
| To assess change in portal vein velocity after graft reperfusion. |
Baseline,
After portal vein reperfusion,
After hepatic artery reperfusion |
| To note any other significant findings in TEE. |
Baseline,
After portal vein reperfusion,
After hepatic artery reperfusion |
| To note any complications related to TEE. |
Baseline,
After portal vein reperfusion,
After hepatic artery reperfusion |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/12/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Liver
Transplantation is a major surgery associated with severe haemodynamic changes.
Transesophageal
Echocardiography (TEE) helps in real-time evaluation of hemodynamics of the
patient and can play a vital role in management of such patients. As of now, TEE has primarily been used for
evaluation of cardiac structures and hemodynamics in patients undergoing liver
transplantation. However, with the advancement of technology, the role of TEE
has expanded beyond the cardiac evaluation of the patients. There are also some
reports about the utility of TEE for portal vein and hepatic vein evaluation in
patients undergoing liver transplantation.
Immediate evaluation of portal vein and hepatic vein after graft
reperfusion is of utmost importance for the early detection and correction of
vascular complications. Currently, an in-field intraoperative doppler
sonography of the hepatic vasculature is a standard practice. But this practice
has some limitations, like the requirement of a radiologist present in the OR,
and interference with the surgical field and a possible breach in sterility. On
the other hand, TEE can provide an immediate, quick and repeated assessment of
hepatic vasculature without risking any breach in field sterility.
As per our literature search, assessment of
hepatic vasculature after graft reperfusion using TEE is limited. Hence, this
study aims to evaluate portal vein, hepatic vein and hepatic artery using TEE
during liver transplantation.
|