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

Study Overview
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Brief Summary
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Temporary portocaval Shunt during recipient hepatectomy improves intra operative parameters and morbidity in LDLT recipients

Detailed Description
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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.

Official Title
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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

Conditions
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Portosystemic Shunt

Intervention / Treatment
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* Procedure: Temporary Portocaval Shunt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) All Adult LDLT Recipients at ILBS, New Delhi Exclusion Criteria: Acute Liver Failure as an indication for transplant Pediatric transplants Presence of Yerdel grade III and grade IV Portal vein thrombosis Presence of significant portosystemic shunting (greater than 10mm) in pre operative period. Patients who have undergone TIPS procedure. Hypercoagulable states like Budd-Chiari syndrome Refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomised Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A-Shunt group<br>Patients who undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation | Procedure: Temporary Portocaval Shunt<br>* In Temorary Portocaval Shunt Group (TPCS group), Hilar dissection( division of Hepatic artery, Bileduct) is followed by temporary portocaval shunt formation during recipient Hepatectomy.<br>|
| No Intervention: Group B-No Shunt group<br>Patients who donot undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure between two groups at fixed time points | 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 | Noradrenaline and Vasopressin requirement in milliliter/hour | T0- At the beginning of the procedure | 
| Lactate level between two groups at fixed time points | 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 | 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 | Noradrenaline and Vasopressin requirement in milliliter/hour | T1- During procedure- Before portocaval shunt formation | 
| Lactate level between two groups at fixed time points | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Noradrenaline and Vasopressin requirement in milliliter/hour | T4- During procedure- Before closure of abdomen | 
| Lactate level between two groups at fixed time points | Lactate levels are documented from Arterial Blood Gas analysis | T4- During procedure- Before closure of abdomen | 
| Blood loss between two groups during intraoperative period | Blood loss during the procedure is measured in milliliter | During Procedure | 
| Duration of surgery between two groups. | 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. | 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. | Serum Creatinine is measured in milligram per deciliter | Number of days post transplantation procedure (upto 45 days) | 
| Urine output between two groups | Urine output during the transplantation procedure is measured in milliliter | During Transplantation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare tolerance to enteral feed between two groups | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temporary Portocaval shunt, Recipient Hepatectomy, Liver transplantation