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

Portosystemic Shunt Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05385120
• Other study ID #: IEC/2021/91/MA04
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: March 2022
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Manoj Kumar YL, MBBS, MS
• Phone: 9164313430
• Email: manojkumaryl91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Portosystemic Shunt

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

References & Publications (5)

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 utili — View Citation

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):9 — View Citation

Ghinolfi D, Martí J, Rodríguez-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 I — View Citation

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. — View Citation

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Ionotropes requirement between two groups at fixed time points	Noradrenaline and Vasopressin requirement in milliliter/hour	T0- At the beginning of the procedure
Primary	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
Primary	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
Primary	Ionotropes requirement between two groups at fixed time points	Noradrenaline and Vasopressin requirement in milliliter/hour	T1- During procedure- Before portocaval shunt formation
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Ionotropes requirement between two groups at fixed time points	Noradrenaline and Vasopressin requirement in milliliter/hour	T4- During procedure- Before closure of abdomen
Primary	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
Primary	Blood loss between two groups during intraoperative period	Blood loss during the procedure is measured in milliliter	During Procedure
Primary	Duration of surgery between two groups.	Duration between incision time to closure of abdomen is noted in minutes	During Procedure
Primary	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)
Primary	=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)
Primary	Urine output between two groups	Urine output during the transplantation procedure is measured in milliliter	During Transplantation procedure
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)