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
|
|
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
|
|
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. |