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

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: Not yet recruiting
• Conditions: Portosystemic Shunt
• Intervention / Treatment: Procedure: Temporary Portocaval Shunt

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: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manoj Kumar YL, MBBS, MS; Phone Number: 9164313430; Email: manojkumaryl91@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Publications and helpful links

General Publications

• Figueras J, Llado L, Ramos E, Jaurrieta E, Rafecas A, Fabregat J, Torras J, Sabate A, Dalmau A. Temporary portocaval shunt during liver transplantation with vena cava preservation. Results of a prospective randomized study. Liver Transpl. 2001 Oct;7(10):904-11. doi: 10.1053/jlts.2001.27870.
• Arzu GD, De Ruvo N, Montalti R, Masetti M, Begliomini B, Di Benedetto F, Rompianesi G, Di Sandro S, Smerieri N, D'Amico G, Vezzelli E, Iemmolo RM, Romano A, Ballarin R, Guerrini GP, De Blasiis MG, Spaggiari M, Gerunda GE. Temporary porto-caval shunt utility during orthotopic liver transplantation. Transplant Proc. 2008 Jul-Aug;40(6):1937-40. doi: 10.1016/j.transproceed.2008.06.001.
• Ghinolfi D, Marti J, Rodriguez-Laiz G, Sturdevant M, Iyer K, Bassi D, Scher C, Schwartz M, Schiano T, Sogawa H, del Rio Martin J. The beneficial impact of temporary porto-caval shunt in orthotopic liver transplantation: a single center analysis. Transpl Int. 2011 Mar;24(3):243-50. doi: 10.1111/j.1432-2277.2010.01168.x. Epub 2010 Sep 28.
• Kim JD, Choi DL. Beneficial impact of temporary portocaval shunt in living-donor liver transplantation with a difficult total hepatectomy. Transplant Proc. 2015 Apr;47(3):694-9. doi: 10.1016/j.transproceed.2014.12.036.
• Pratschke S, Meimarakis G, Bruns CJ, Kaspar M, Prix N, Zachoval R, Guba M, Jauch KW, Loehe F, Angele MK. Temporary intraoperative porto-caval shunt: useless or beneficial in piggy back liver transplantation? Transpl Int. 2013 Jan;26(1):90-8. doi: 10.1111/tri.12007. Epub 2012 Nov 29.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 25, 2022
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): August 30, 2023

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Liver transplantation; Temporary Portocaval shunt; Recipient Hepatectomy
• Other Study ID 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