To Compare the Outcome of Temporary Portocaval Shunt During Recipient Hepatectomy Versus No Shunt in Adult Elective Live Donor Liver Transplantation.

May 19, 2022 updated by: Institute of Liver and Biliary Sciences, India

To Compare the Outcome of Temporary Portocaval Shunt During Recipient Hepatectomy Versus No Shunt in Adult Elective Live Donor Liver Transplantation- A Prospective Randomised Pilot Study

Temporary portocaval Shunt during recipient hepatectomy improves intra operative parameters and morbidity in LDLT recipients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All patients satisfying the inclusion criteria, written informed consent will be taken and patients are randomized into intervention group ( Portocaval Shunt Group) and Non intervention group ( No Shunt Group).Patients from both the groups will be assessed for Hemodynamic parameters, Urine Output, Blood loss, blood products requirement , Duration of surgery during the procedure. They will be assessed for renal function, presence of sepsis, Morbidity, early graft dysfunction, ICU stay and total hospital stay in the post operative period.All patients will be followed up till discharge from hospital.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1) All Adult LDLT Recipients at ILBS, New Delhi

Exclusion Criteria:

  1. Acute Liver Failure as an indication for transplant
  2. Pediatric transplants
  3. Presence of Yerdel grade III and grade IV Portal vein thrombosis
  4. Presence of significant portosystemic shunting (greater than 10mm) in pre operative period.
  5. Patients who have undergone TIPS procedure.
  6. Hypercoagulable states like Budd-Chiari syndrome
  7. Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A-Shunt group
Patients who undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation
Procedure: Temporary Portocaval Shunt
In Temorary Portocaval Shunt Group (TPCS group), Hilar dissection( division of Hepatic artery, Bileduct) is followed by temporary portocaval shunt formation during recipient Hepatectomy.
No Intervention: Group B-No Shunt group
Patients who donot undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood Pressure between two groups at fixed time points
Time Frame: T0- At the beginning of the procedure
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmHg
T0- At the beginning of the procedure
Ionotropes requirement between two groups at fixed time points
Time Frame: T0- At the beginning of the procedure
Noradrenaline and Vasopressin requirement in milliliter/hour
T0- At the beginning of the procedure
Lactate level between two groups at fixed time points
Time Frame: T0- At the beginning of the procedure
Lactate levels are documented from Arterial Blood Gas analysis
T0- At the beginning of the procedure
Blood Pressure between two groups at fixed time points
Time Frame: T1- During procedure- Before portocaval shunt formation
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmHg
T1- During procedure- Before portocaval shunt formation
Ionotropes requirement between two groups at fixed time points
Time Frame: T1- During procedure- Before portocaval shunt formation
Noradrenaline and Vasopressin requirement in milliliter/hour
T1- During procedure- Before portocaval shunt formation
Lactate level between two groups at fixed time points
Time Frame: T1- During procedure- Before portocaval shunt formation
Lactate levels are documented from Arterial Blood Gas analysis
T1- During procedure- Before portocaval shunt formation
Blood Pressure between two groups at fixed time points
Time Frame: T2- During procedure- Just Before Reperfusion of graft liver
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg
T2- During procedure- Just Before Reperfusion of graft liver
Ionotropes requirement between two groups at fixed time points
Time Frame: T2- During procedure- Just Before Reperfusion of graft liver
Noradrenaline and Vasopressin requirement in milliliter/hour
T2- During procedure- Just Before Reperfusion of graft liver
Lactate level between two groups at fixed time points
Time Frame: T2- During procedure- Just Before Reperfusion of graft liver
Lactate levels are documented from Arterial Blood Gas analysis
T2- During procedure- Just Before Reperfusion of graft liver
Blood Pressure between two groups at fixed time points
Time Frame: T3- During procedure- 5 minutes after reperfusion of graft liver
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg
T3- During procedure- 5 minutes after reperfusion of graft liver
Ionotropes requirement between two groups at fixed time points
Time Frame: T3- During procedure- 5 minutes after reperfusion of graft liver
Noradrenaline and Vasopressin requirement in milliliter/hour
T3- During procedure- 5 minutes after reperfusion of graft liver
Lactate level between two groups at fixed time points
Time Frame: T3- During procedure- 5 minutes after reperfusion of graft liver
Lactate levels are documented from Arterial Blood Gas analysis
T3- During procedure- 5 minutes after reperfusion of graft liver
Blood Pressure between two groups at fixed time points
Time Frame: T4- During procedure- Before closure of abdomen
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg
T4- During procedure- Before closure of abdomen
Ionotropes requirement between two groups at fixed time points
Time Frame: T4- During procedure- Before closure of abdomen
Noradrenaline and Vasopressin requirement in milliliter/hour
T4- During procedure- Before closure of abdomen
Lactate level between two groups at fixed time points
Time Frame: T4- During procedure- Before closure of abdomen
Lactate levels are documented from Arterial Blood Gas analysis
T4- During procedure- Before closure of abdomen
Blood loss between two groups during intraoperative period
Time Frame: During Procedure
Blood loss during the procedure is measured in milliliter
During Procedure
Duration of surgery between two groups.
Time Frame: During Procedure
Duration between incision time to closure of abdomen is noted in minutes
During Procedure
Increase in creatinine levels of Increase 1.5-1.9 times from baseline in the post op period.
Time Frame: Number of days post transplantation procedure (upto 45 days)
Serum Creatinine is measured in milligram per deciliter
Number of days post transplantation procedure (upto 45 days)
≥0.3 mg/dl increase within 48 h or Urine output < 0.5 ml/kg/h for 6-12 h in the post op period.
Time Frame: Number of days post transplantation procedure (upto 45 days)
Serum Creatinine is measured in milligram per deciliter
Number of days post transplantation procedure (upto 45 days)
Urine output between two groups
Time Frame: During Transplantation procedure
Urine output during the transplantation procedure is measured in milliliter
During Transplantation procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To compare tolerance to enteral feed between two groups
Time Frame: Number of days post transplantation procedure (upto 45 days)
Tolerance to NG feed is defined by absence of bloating, nausea, vomiting, abdominal distention or ileus
Number of days post transplantation procedure (upto 45 days)
Endotoxin levels
Time Frame: Levels of Serum endotoxin levels in pre op and 12 hours after surgery
Serum endotoxin levels increases in cases of bowel congestion and hemodynamic instability when portal vein is clamped during recipient hepatectomy
Levels of Serum endotoxin levels in pre op and 12 hours after surgery
Number of patients with Early allograft dysfunction
Time Frame: For 5 consecutive days after day 7
Early allograft dysfunction using criteria defined - total bilirubin >10 mg/dL, INR >1.6 and serum urea >100 mg/dL, for five consecutive days after day 7
For 5 consecutive days after day 7
Incidence of Morbidity
Time Frame: Number of days post transplantation procedure (upto 45 days)
Morbidity is defined by Clavein Dindo Classification - >/=3. Sepsis as defined by Sepsis- 3 criteria, presence of 2 or more of the following 1.altered mentation, 2.respiratory rate ≥22 breaths/min 3.systolic blood pressure ≤100 mm Hg
Number of days post transplantation procedure (upto 45 days)
Incidence of sepsis
Time Frame: Number of days post transplantation procedure (upto 45 days)
Morbidity is defined by Clavein Dindo Classification - >/=3. Sepsis as defined by Sepsis- 3 criteria, presence of 2 or more of the following 1.altered mentation, 2.respiratory rate ≥22 breaths/min 3.systolic blood pressure ≤100 mm Hg
Number of days post transplantation procedure (upto 45 days)
Number of days of ICU stay
Time Frame: Number of days post transplantation procedure (upto 45 days)
Day patient shifted from ICU to ward is documented as total ICU stay. Day patient is discharged from hospital is documented for total hospital stay
Number of days post transplantation procedure (upto 45 days)
Number of days of hospital stay
Time Frame: Number of days post transplantation procedure (upto 45 days)
Day patient shifted from ICU to ward is documented as total ICU stay. Day patient is discharged from hospital is documented for total hospital stay
Number of days post transplantation procedure (upto 45 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Liver and Biliary Sciences, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IEC/2021/91/MA04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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