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

Not Applicable

• Conditions: Portosystemic Shunt
• Interventions: Procedure: Temporary Portocaval Shunt

• Registration Number: NCT05385120
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

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

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 Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-05-19
• Last Update Submitted: 2022-05-19
• Study First Posted: 2022-05-23
• Last Update Posted: 2022-05-23
• Study Start: 2022-05-25
• Primary Completion: 2023-07-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A-Shunt group	Temporary Portocaval Shunt	Patients who undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation

Primary Outcome Measures

Name	Time	Method
Ionotropes requirement between two groups at fixed time points	T4- During procedure- Before closure of abdomen	Noradrenaline and Vasopressin requirement in milliliter/hour
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
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

Name	Time	Method
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
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
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
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 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
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