To Compare the Outcome of Temporary Portocaval Shunt During Recipient Hepatectomy Versus No Shunt in Adult Elective Live Donor Liver Transplantation.
Study Details
Study Description
Brief Summary
Temporary portocaval Shunt during recipient hepatectomy improves intra operative parameters and morbidity in LDLT recipients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- Blood Pressure between two groups at fixed time points [T0- At the beginning of the procedure]
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmHg
- Ionotropes requirement between two groups at fixed time points [T0- At the beginning of the procedure]
Noradrenaline and Vasopressin requirement in milliliter/hour
- Lactate level between two groups at fixed time points [T0- At the beginning of the procedure]
Lactate levels are documented from Arterial Blood Gas analysis
- Blood Pressure between two groups at fixed time points [T1- During procedure- Before portocaval shunt formation]
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmHg
- Ionotropes requirement between two groups at fixed time points [T1- During procedure- Before portocaval shunt formation]
Noradrenaline and Vasopressin requirement in milliliter/hour
- Lactate level between two groups at fixed time points [T1- During procedure- Before portocaval shunt formation]
Lactate levels are documented from Arterial Blood Gas analysis
- Blood Pressure between two groups at fixed time points [T2- During procedure- Just Before Reperfusion of graft liver]
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg
- Ionotropes requirement between two groups at fixed time points [T2- During procedure- Just Before Reperfusion of graft liver]
Noradrenaline and Vasopressin requirement in milliliter/hour
- Lactate level between two groups at fixed time points [T2- During procedure- Just Before Reperfusion of graft liver]
Lactate levels are documented from Arterial Blood Gas analysis
- Blood Pressure between two groups at fixed time points [T3- During procedure- 5 minutes after reperfusion of graft liver]
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg
- Ionotropes requirement between two groups at fixed time points [T3- During procedure- 5 minutes after reperfusion of graft liver]
Noradrenaline and Vasopressin requirement in milliliter/hour
- Lactate level between two groups at fixed time points [T3- During procedure- 5 minutes after reperfusion of graft liver]
Lactate levels are documented from Arterial Blood Gas analysis
- Blood Pressure between two groups at fixed time points [T4- During procedure- Before closure of abdomen]
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg
- Ionotropes requirement between two groups at fixed time points [T4- During procedure- Before closure of abdomen]
Noradrenaline and Vasopressin requirement in milliliter/hour
- Lactate level between two groups at fixed time points [T4- During procedure- Before closure of abdomen]
Lactate levels are documented from Arterial Blood Gas analysis
- Blood loss between two groups during intraoperative period [During Procedure]
Blood loss during the procedure is measured in milliliter
- Duration of surgery between two groups. [During Procedure]
Duration between incision time to closure of abdomen is noted in minutes
- Increase in creatinine levels of Increase 1.5-1.9 times from baseline in the post op period. [Number of days post transplantation procedure (upto 45 days)]
Serum Creatinine is measured in milligram per deciliter
- ≥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. [Number of days post transplantation procedure (upto 45 days)]
Serum Creatinine is measured in milligram per deciliter
- Urine output between two groups [During Transplantation procedure]
Urine output during the transplantation procedure is measured in milliliter
Secondary Outcome Measures
- To compare tolerance to enteral feed between two groups [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
- Endotoxin levels [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
- Number of patients with Early allograft dysfunction [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
- Incidence of Morbidity [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
- Incidence of sepsis [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 of ICU stay [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 of hospital stay [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
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Institute of Liver and Biliary Sciences, India
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IEC/2021/91/MA04