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

NCT05385120 | Unknown

• 1 other identifier: IEC/2021/91/MA04
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Portosystemic Shunt

Keywords

Temporary Portocaval shunt; Recipient Hepatectomy; Liver transplantation

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (7)

• To compare tolerance to enteral feed between two groups

  Number of days post transplantation procedure (upto 45 days)

• Endotoxin levels

  Levels of Serum endotoxin levels in pre op and 12 hours after surgery

• Number of patients with Early allograft dysfunction

  For 5 consecutive days after day 7

• Incidence of Morbidity

  Number of days post transplantation procedure (upto 45 days)

• Incidence of sepsis

  Number of days post transplantation procedure (upto 45 days)

Study Arms (2)

Group A-Shunt group

EXPERIMENTAL

Patients who undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation

Procedure: Temporary Portocaval Shunt

Group B-No Shunt group

NO INTERVENTION

Patients who donot undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation

Interventions

Temporary Portocaval Shunt PROCEDURE

In Temorary Portocaval Shunt Group (TPCS group), Hilar dissection( division of Hepatic artery, Bileduct) is followed by temporary portocaval shunt formation during recipient Hepatectomy.

Group A-Shunt group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) All Adult LDLT Recipients at ILBS, New Delhi

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Related Publications (5)

• 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.

  PMID: 11679990 RESULT

• 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.

  PMID: 18675094 RESULT

• 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.

  PMID: 20875093 RESULT

• 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.

  PMID: 25891713 RESULT

• 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.

  PMID: 23237579 RESULT

Central Study Contacts

Manoj Kumar YL, MBBS, MS

CONTACT

9164313430; manojkumaryl91@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Randomised Pilot study

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: May 23, 2022
• Study Start: May 25, 2022
• Primary Completion: July 30, 2023
• Study Completion: August 30, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share