Clinical trial NCT05385120: To Compare the Outcome of Temporary Portocaval Shunt During Recipient Hepatectomy Versus No Shunt in Adult Elective Live Donor Liver Transplantation.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Portosystemic Shunt
Keywords: Temporary Portocaval shunt
Recipient Hepatectomy
Liver transplantation
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomised Pilot study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure between two groups at fixed time points
timeFrame: T0- At the beginning of the procedure
measure: Ionotropes requirement between two groups at fixed time points
timeFrame: T0- At the beginning of the procedure
measure: Lactate level between two groups at fixed time points
timeFrame: T0- At the beginning of the procedure
measure: Blood Pressure between two groups at fixed time points
timeFrame: T1- During procedure- Before portocaval shunt formation
measure: Ionotropes requirement between two groups at fixed time points
timeFrame: T1- During procedure- Before portocaval shunt formation
measure: Lactate level between two groups at fixed time points
timeFrame: T1- During procedure- Before portocaval shunt formation
measure: Blood Pressure between two groups at fixed time points
timeFrame: T2- During procedure- Just Before Reperfusion of graft liver
measure: Ionotropes requirement between two groups at fixed time points
timeFrame: T2- During procedure- Just Before Reperfusion of graft liver
measure: Lactate level between two groups at fixed time points
timeFrame: T2- During procedure- Just Before Reperfusion of graft liver
measure: Blood Pressure between two groups at fixed time points
timeFrame: T3- During procedure- 5 minutes after reperfusion of graft liver
measure: Ionotropes requirement between two groups at fixed time points
timeFrame: T3- During procedure- 5 minutes after reperfusion of graft liver
measure: Lactate level between two groups at fixed time points
timeFrame: T3- During procedure- 5 minutes after reperfusion of graft liver
measure: Blood Pressure between two groups at fixed time points
timeFrame: T4- During procedure- Before closure of abdomen
measure: Ionotropes requirement between two groups at fixed time points
timeFrame: T4- During procedure- Before closure of abdomen
measure: Lactate level between two groups at fixed time points
timeFrame: T4- During procedure- Before closure of abdomen
measure: Blood loss between two groups during intraoperative period
timeFrame: During Procedure
measure: Duration of surgery between two groups.
timeFrame: During Procedure
measure: Increase in creatinine levels of Increase 1.5-1.9 times from baseline in the post op period.
timeFrame: Number of days post transplantation procedure (upto 45 days)
measure: ≥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.
timeFrame: Number of days post transplantation procedure (upto 45 days)
measure: Urine output between two groups
timeFrame: During Transplantation procedure
Secondary outcomes:
measure: To compare tolerance to enteral feed between two groups
timeFrame: Number of days post transplantation procedure (upto 45 days)
measure: Endotoxin levels
timeFrame: Levels of Serum endotoxin levels in pre op and 12 hours after surgery
measure: Number of patients with Early allograft dysfunction
timeFrame: For 5 consecutive days after day 7
measure: Incidence of Morbidity
timeFrame: Number of days post transplantation procedure (upto 45 days)
measure: Incidence of sepsis
timeFrame: Number of days post transplantation procedure (upto 45 days)
measure: Number of days of ICU stay
timeFrame: Number of days post transplantation procedure (upto 45 days)
measure: Number of days of hospital stay
timeFrame: Number of days post transplantation procedure (upto 45 days)
Other outcomes:
Locations:
Study officials:
References:
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):904-11. doi: 10.1053/jlts.2001.27870.
citation: 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.
citation: 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.
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.
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/tri.12007. Epub 2012 Nov 29.