Chronic Liver DiseaseNCT06909175
Comparing Portal Vein Assessment by Intraoperative Doppler and Transesophageal Echocardiography
An observational study of Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Liver transplantation is usually associated with hemodynamic instability. TEE allows for a real time monitoring of cardiac structures and has become a standard of care for liver transplant patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- Transesophageal echocardiography
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteIndia
- Study dates
- 5 Apr 2025to 5 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Chronic liver disease
Who may be able to join
- All patients who have undergone Live donor liver transplant, Age > 18 years
Who cannot join
- Required data is not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Transesophageal Echocardiography and Trans Abdominal Doppler for Portal Vein Assessment in Living Donor Liver Transplantation
Liver transplantation is usually associated with hemodynamic instability. TEE allows for a real time monitoring of cardiac structures and has become a standard of care for liver transplant patients. Society of cardiovascular anaesthesia and American society of anaesthesiologists recommends use of TEE in non-cardiac surgery patients with hemodynamic instability. Also, society for advancement of transplant anaesthesia (SATA) has suggested that TEE usage in cases of liver transplant is safe, effective and improves outcomes. TEE can also provide vital information relating to non-cardiac structures including liver, spleen, kidneys, portal vein, hepatic vein and other major vessels. As of now standard protocol is to do the transabdominal doppler for the assessment of portal vein after the liver graft implantation. Hence, the aim of our study is to compare the transesophageal echocardiography and transabdominal Doppler for assessing portal vein in living donor liver transplantation.
Read the detailed description
Data from all patients who underwent live donor liver transplant surgery at Institute of Liver and Biliary Sciences, New Delhi and in whom TEE probe was inserted will be collected and analysed.
- Conditions
- Chronic Liver Disease
- Being tested
- Transesophageal echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal echocardiographyDevice
Portal vein velocities were measured using TEE and intraoperative doppler in patients undergoing living donor liver transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the portal vein flow velocity using transesophageal echocardiography and transabdominal Doppler during live donor liver transplant surgery.
Measured: intraoperative period
Secondary outcomes (1)
any TEE related complication
Measured: intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start5 Apr 2025
- Primary completion5 May 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaurav Sindwani, Institute of Liver and Biliary Sciences, India
- Investigators
- Gaurav Sindwani, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909175
- Sponsor's protocol ID
- ILBSindia5
- Status last verified
- Jun 2025
- First submitted
- 27 Mar 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Transesophageal Echocardiography and Trans Abdominal Doppler for Portal Vein Assessment in Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT06909175
- Acronym / sponsor ID
- ILBSindia5
- Conditions
- Chronic Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Liver transplantation is usually associated with hemodynamic instability. TEE allows for a real time monitoring of cardiac structures and has become a standard of care for liver transplant patients. Society of cardiovascular anaesthesia and American society of anaesthesiologists recommends use of TEE in non-cardiac surgery patients with hemodynamic instability. Also, society for advancement of transplant anaesthesia (SATA) has suggested that TEE usage in cases of liver transplant is safe, effective and improves outcomes. TEE can also provide vital information relating to non-cardiac structures including liver, spleen, kidneys, portal vein, hepatic vein and other major vessels. As of now standard protocol is to do the transabdominal doppler for the assessment of portal vein after the liver graft implantation. Hence, the aim of our study is to compare the transesophageal echocardiography and transabdominal Doppler for assessing portal vein in living donor liver transplantation.
Detailed description
Data from all patients who underwent live donor liver transplant surgery at Institute of Liver and Biliary Sciences, New Delhi and in whom TEE probe was inserted will be collected and analysed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chronic liver disease
Key inclusion criteria (1 listed)
- All patients who have undergone Live donor liver transplant, Age > 18 years
Key exclusion criteria (1 listed)
- Required data is not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal echocardiographyPortal vein velocities were measured using TEE and intraoperative doppler in patients undergoing living donor liver transplantation | Device | – |
Primary outcome
To compare the portal vein flow velocity using transesophageal echocardiography and transabdominal Doppler during live donor liver transplant surgery.
Time frame: intraoperative period
1 secondary outcome
any TEE related complication
Time frame: intraoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaurav Sindwani, MD principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the portal vein flow velocity using transesophageal echocardiography and transabdominal Doppler during live donor liver transplant surgery. (time frame: intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.