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

NCT ID: NCT05385120

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2023-08-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Portosystemic Shunt

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Randomised Pilot study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A-Shunt group

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

Group Type EXPERIMENTAL

Temporary Portocaval Shunt

Intervention Type 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 B-No Shunt group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Manoj Kumar YL, MBBS, MS

Role: CONTACT

9164313430

References

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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.

Reference Type RESULT
PMID: 11679990 (View on PubMed)

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.

Reference Type RESULT
PMID: 18675094 (View on PubMed)

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.

Reference Type RESULT
PMID: 20875093 (View on PubMed)

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.

Reference Type RESULT
PMID: 25891713 (View on PubMed)

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.

Reference Type RESULT
PMID: 23237579 (View on PubMed)

Other Identifiers

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IEC/2021/91/MA04

Identifier Type: -

Identifier Source: org_study_id

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