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CTRI Number  CTRI/2021/10/037235 [Registered on: 11/10/2021] Trial Registered Prospectively
Last Modified On: 08/10/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of hepatic vessels by transesophageal echocardiography during living donor liver transplantation. 
Scientific Title of Study   Trans-esophageal echocardiographic assessment of hepatic vasculature in patients undergoing living donor liver transplantation – A Prospective Observational study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swati Gupta 
Designation  Senior Resident 
Affiliation  Institute of liver and biliary sciences 
Address  Department of Anesthesia, Third Floor, Phase 1, ILBS hospital, Vasant kunj
Department of Anesthesia, Third floor, Phase 1, Vasant Kunj, New Delhi, 110070
South
DELHI
110070
India 
Phone  8700451515  
Fax    
Email  1988swatigupta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gaurav Sindwani 
Designation  Associate Professor 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Department of Anesthesia, Third Floor, Phase 1, ILBS hospital, Vasant Kunj
Department of Anesthesia, Third floor, Phase 1, Vasant Kunj, New Delhi, 110070
South
DELHI
110070
India 
Phone  8728089898  
Fax    
Email  drsindwani25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gaurav Sindwani 
Designation  Associate Professor 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Department of Anesthesia, Third Floor, Phase 1, ILBS hospital, Vasant Kunj
Department of Anesthesia, Third floor, Phase 1, Vasant Kunj, New Delhi, 110070
South
DELHI
110070
India 
Phone  8728089898  
Fax    
Email  drsindwani25@gmail.com  
 
Source of Monetary or Material Support  
Institute of Liver and Biliary sciences, D-1 Block, Vasant kunj, New Delhi, Pin - 110070 
 
Primary Sponsor  
Name  Dr Swati Gupta 
Address  Room No. 3305, Department of Anesthesia, Third Floor, Phase 1, ILBS hospital  
Type of Sponsor  Other [self] 
 
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 Gaurav Sindwani  Institute of Liver and Biliary sciences  Room No. 3311, Department of Anaesthesia
South
DELHI 
91872808989

drsindwani25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K740||Hepatic fibrosis,  
 
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  All patients undergoing living donor liver transplantation 
 
ExclusionCriteria 
Details  1. Previous history of esophageal pathology like stricture, malignancy, diverticulum, laceration or history of previous esophageal surgery.
2. Esophageal varices > grade 2, gastric varices or active esophagitis.
4. History of recent upper gastro-intestinal bleed (within 1 month).
5. History of variceal banding within last month
5. Patient not willing to provide informed consent.
 
 
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 IVC flow velocities using TEE immediately after the reperfusion during live donor liver transplant surgery.  Baseline, 4 hours, 8 hours, 12 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the angle on TEE at which portal vein, hepatic vein and ivc are seen   24 Hours 
Any major finding on TEE during liver transplantation  24 Hours 
Any complication related to TEE  48 Hours 
 
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)   14/10/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Liver transplantation is considered a standard of care and life-saving procedure for patients suffering from end-stage liver disease (ESLD). Due to cirrhotic cardiomyopathy, these patients usually have cardiac dysfunction which is not detected on routine testing but manifests during stress conditions of surgery. The expanding role of transesophageal echocardiography (TEE) in intraoperative monitoring is now increasing gradually and it is being used away from the context of cardiac surgeries alone. The American Association for anesthetists on liver diseases has recommended that TEE should be used for all orthotropic liver transplant cases. Similarly, the European association of echocardiography has also recommended for use of TEE in all liver transplant cases. TEE can be used not only to monitor cardiac changes but can also give valuable information about other organs such as the lungs and liver. In a case report by Khurmi et al,  they used TEE to diagnose hepatic venous and IVC thrombus intra-operatively during liver transplant surgery. The anatomic proximity of the distal esophagus and gastric antrum to the hepatic vein, portal vein, and inferior vena cava make TEE an idol monitor for their proper assessment during liver transplant surgery. Hence, in this study, we aim to evaluate the hepatic vein, portal vein, and inferior vena cava by TEE during living donor liver transplant surgery.

 
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