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Portosystemic ShuntNCT05385120

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

A study testing Temporary Portocaval Shunt in people with Portosystemic Shunt, run by Institute of Liver and Biliary Sciences, India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Temporary portocaval Shunt during recipient hepatectomy improves intra operative parameters and morbidity in LDLT recipients Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Portosystemic Shunt
What is being tested?
Temporary Portocaval Shunt
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
25 May 2022to 30 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Manoj Kumar YL, MBBS, MS contact

9164313430

manojkumaryl91@gmail.com

About this study

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

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

Read the 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.

Being tested
Temporary Portocaval Shunt
Keywords
Temporary Portocaval shunt, Recipient Hepatectomy, Liver transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Temporary Portocaval ShuntProcedure or surgery

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

Study groups in NCT05385120
Study groupRoleWhat they receive
Group A-Shunt groupExperimentalPatients who undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation
Receives: Procedure: Temporary Portocaval Shunt
Group B-No Shunt groupNo interventionPatients who donot undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure between two groups at fixed time points

    Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmHg

    Measured: T0- At the beginning of the procedure

  2. Ionotropes requirement between two groups at fixed time points

    Noradrenaline and Vasopressin requirement in milliliter/hour

    Measured: T0- At the beginning of the procedure

  3. Lactate level between two groups at fixed time points

    Lactate levels are documented from Arterial Blood Gas analysis

    Measured: T0- At the beginning of the procedure

  4. Blood Pressure between two groups at fixed time points

    Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmHg

    Measured: T1- During procedure- Before portocaval shunt formation

  5. Ionotropes requirement between two groups at fixed time points

    Noradrenaline and Vasopressin requirement in milliliter/hour

    Measured: T1- During procedure- Before portocaval shunt formation

  6. Lactate level between two groups at fixed time points

    Lactate levels are documented from Arterial Blood Gas analysis

    Measured: T1- During procedure- Before portocaval shunt formation

  7. Blood Pressure between two groups at fixed time points

    Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg

    Measured: T2- During procedure- Just Before Reperfusion of graft liver

  8. Ionotropes requirement between two groups at fixed time points

    Noradrenaline and Vasopressin requirement in milliliter/hour

    Measured: T2- During procedure- Just Before Reperfusion of graft liver

  9. Lactate level between two groups at fixed time points

    Lactate levels are documented from Arterial Blood Gas analysis

    Measured: T2- During procedure- Just Before Reperfusion of graft liver

  10. Blood Pressure between two groups at fixed time points

    Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg

    Measured: T3- During procedure- 5 minutes after reperfusion of graft liver

  11. Ionotropes requirement between two groups at fixed time points

    Noradrenaline and Vasopressin requirement in milliliter/hour

    Measured: T3- During procedure- 5 minutes after reperfusion of graft liver

  12. Lactate level between two groups at fixed time points

    Lactate levels are documented from Arterial Blood Gas analysis

    Measured: T3- During procedure- 5 minutes after reperfusion of graft liver

  13. Blood Pressure between two groups at fixed time points

    Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg

    Measured: T4- During procedure- Before closure of abdomen

  14. Ionotropes requirement between two groups at fixed time points

    Noradrenaline and Vasopressin requirement in milliliter/hour

    Measured: T4- During procedure- Before closure of abdomen

  15. Lactate level between two groups at fixed time points

    Lactate levels are documented from Arterial Blood Gas analysis

    Measured: T4- During procedure- Before closure of abdomen

  16. Blood loss between two groups during intraoperative period

    Blood loss during the procedure is measured in milliliter

    Measured: During Procedure

  17. Duration of surgery between two groups.

    Duration between incision time to closure of abdomen is noted in minutes

    Measured: During Procedure

  18. 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

    Measured: Number of days post transplantation procedure (upto 45 days)

  19. ≥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

    Measured: Number of days post transplantation procedure (upto 45 days)

  20. Urine output between two groups

    Urine output during the transplantation procedure is measured in milliliter

    Measured: During Transplantation procedure

Secondary outcomes (7)

  1. 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

    Measured: Number of days post transplantation procedure (upto 45 days)

  2. Endotoxin levels

    Serum endotoxin levels increases in cases of bowel congestion and hemodynamic instability when portal vein is clamped during recipient hepatectomy

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

  3. 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

    Measured: For 5 consecutive days after day 7

  4. 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

    Measured: Number of days post transplantation procedure (upto 45 days)

  5. 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

    Measured: Number of days post transplantation procedure (upto 45 days)

  6. 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

    Measured: Number of days post transplantation procedure (upto 45 days)

  7. 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

    Measured: Number of days post transplantation procedure (upto 45 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2022
  2. Study start25 May 2022 (estimated)
  3. Primary completion30 Jul 2023 (estimated)
  4. Study completion30 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Randomised Pilot study
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05385120
Sponsor's protocol ID
IEC/2021/91/MA04
Status last verified
Mar 2022
First submitted
29 Mar 2022
Last updated
23 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11679990

  • 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.

    PubMed 18675094

  • 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.

    PubMed 20875093

  • 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.

    PubMed 25891713

  • 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.

    PubMed 23237579

Questions about this trial

What is this clinical trial studying?

A study testing Temporary Portocaval Shunt in people with Portosystemic Shunt, run by Institute of Liver and Biliary Sciences, India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Manoj Kumar YL, MBBS, MS (9164313430, manojkumaryl91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure between two groups at fixed time points (time frame: T0- At the beginning of the procedure). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05385120, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.

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