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

Sponsors

Lead Sponsor: Institute of Liver and Biliary Sciences, India

Source 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.

Overall Status Not yet recruiting
Start Date 2022-05-25
Completion Date 2023-08-30
Primary Completion Date 2023-07-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Blood Pressure between two groups at fixed time points T0- At the beginning of the procedure
Ionotropes requirement between two groups at fixed time points T0- At the beginning of the procedure
Lactate level between two groups at fixed time points T0- At the beginning of the procedure
Blood Pressure between two groups at fixed time points T1- During procedure- Before portocaval shunt formation
Ionotropes requirement between two groups at fixed time points T1- During procedure- Before portocaval shunt formation
Lactate level between two groups at fixed time points T1- During procedure- Before portocaval shunt formation
Blood Pressure between two groups at fixed time points T2- During procedure- Just Before Reperfusion of graft liver
Ionotropes requirement between two groups at fixed time points T2- During procedure- Just Before Reperfusion of graft liver
Lactate level between two groups at fixed time points T2- During procedure- Just Before Reperfusion of graft liver
Blood Pressure between two groups at fixed time points T3- During procedure- 5 minutes after reperfusion of graft liver
Ionotropes requirement between two groups at fixed time points T3- During procedure- 5 minutes after reperfusion of graft liver
Lactate level between two groups at fixed time points T3- During procedure- 5 minutes after reperfusion of graft liver
Blood Pressure between two groups at fixed time points T4- During procedure- Before closure of abdomen
Ionotropes requirement between two groups at fixed time points T4- During procedure- Before closure of abdomen
Lactate level between two groups at fixed time points T4- During procedure- Before closure of abdomen
Blood loss between two groups during intraoperative period During Procedure
Duration of surgery between two groups. During Procedure
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)
≥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)
Urine output between two groups During Transplantation procedure
Secondary Outcome
Measure Time Frame
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)
Number of days of ICU stay Number of days post transplantation procedure (upto 45 days)
Number of days of hospital stay Number of days post transplantation procedure (upto 45 days)
Enrollment 40
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Temporary Portocaval Shunt

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

Arm Group Label: Group A-Shunt group

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Verification Date

2022-03-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Group A-Shunt group

Type: Experimental

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

Label: Group B-No Shunt group

Type: No Intervention

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: A Randomised Pilot study

Primary Purpose: Supportive Care

Masking: None (Open Label)

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