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Impact of Splenic Artery Ligation in LDLT for Patients With Portal Hypertension

Primary Purpose

Living Donor Liver Transplantation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
splenic artery ligation
No intervention
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Living Donor Liver Transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients undergoing Living Donor Liver Transplantation(LDLT) accepted according to hospital protocol.
  • Patients who have Portal Venous Pressure (PVP) > 15 mm Hg after reperfusion .

Exclusion Criteria:

  • Patients who have Portal Venous Pressure (PVP) > 15 mm Hg after reperfusion.
  • Patients who had splenectomy.
  • Patients who have splenic artery aneurysm.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Patients who undergo Splenic artery ligation

    No splenic artery ligation

    Arm Description

    If inclusion criteria are met, these group of patients will undergo splenic artery ligation .

    If inclusion criteria are met, these group of patients will not undergo splenic artery ligation.

    Outcomes

    Primary Outcome Measures

    Incidence of early graft dysfunction
    Number of patients who develop early graft dysfunction in each group
    Time to normalisation of ascites output
    time to normalisation of ascites output (in days)
    Time to normalisation of INR
    time to normalisation of INR (in days)
    Time to normalisation of bilirubin
    time to normalisation of bilirubin (in days)

    Secondary Outcome Measures

    Morbidity
    Morbidity as per Clavein Dindo classification
    ICU stay
    Duration of ICU stay (in days)
    Mortality
    death
    Total hospital stay
    duration of total stay in hospital after liver transplantation (in days)

    Full Information

    First Posted
    July 25, 2021
    Last Updated
    August 14, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04988100
    Brief Title
    Impact of Splenic Artery Ligation in LDLT for Patients With Portal Hypertension
    Official Title
    Impact of Splenic Artery Ligation in Living Donor Liver Transplantation for Patients With Portal Hypertension on Early Graft Function.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In this study, the investigators aim to prove that performing splenic artery ligation in living donor liver transplantation for patients with portal hypertension is beneficial for early graft function postoperatively. The investigators will be analyzing trend of LFT's (liver function tests) after surgery, time for normalization of bilirubin, INR (international normalised ratio) and decrease in ascites, morbidity, mortality, ICU (intensive care unit) and total hospital stay.
    Detailed Description
    Liver transplantation (LT) is the principal treatment for end-stage liver diseases and selected cases of liver neoplasms . Living donor liver transplantation (LDLT) serves as a sole source of liver graft in some countries that do not allow donation from deceased donors for cultural, social, or religious reasons. Hyperperfusion plays an important role in liver regeneration after LDLT, but it may induce injury in the graft . After the reperfusion of a partial graft, there is a significant increase in the portal flow, but Hepatic artery flow remains constant . Excessive portal vein flow may induce injuries in grafts and may contribute to poor graft function. For satisfactory graft function early after LT, the portal vein pressure (PVP) value after reperfusion should be <15 mm Hg. PVP is the most important hemodynamic factor influencing the functional status of the liver and graft regeneration after LT. The use of Splenic Artery Ligation (SAL) as a simple and safe method to modulate portal flow has been reported . The investigators will evaluate that Splenic artery ligation in living donor liver transplantation for patients with Portal hypertension is feasible and efficient technique to improve early graft function and to decrease morbidity and hospital stay and improve outcomes .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Living Donor Liver Transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients who undergo Splenic artery ligation
    Arm Type
    Experimental
    Arm Description
    If inclusion criteria are met, these group of patients will undergo splenic artery ligation .
    Arm Title
    No splenic artery ligation
    Arm Type
    Active Comparator
    Arm Description
    If inclusion criteria are met, these group of patients will not undergo splenic artery ligation.
    Intervention Type
    Procedure
    Intervention Name(s)
    splenic artery ligation
    Intervention Description
    Splenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas
    Intervention Type
    Procedure
    Intervention Name(s)
    No intervention
    Intervention Description
    Splenic artery is not ligated despite the presence of portal hyperperfusion
    Primary Outcome Measure Information:
    Title
    Incidence of early graft dysfunction
    Description
    Number of patients who develop early graft dysfunction in each group
    Time Frame
    first postoperative month
    Title
    Time to normalisation of ascites output
    Description
    time to normalisation of ascites output (in days)
    Time Frame
    first postoperative month
    Title
    Time to normalisation of INR
    Description
    time to normalisation of INR (in days)
    Time Frame
    first postoperative month
    Title
    Time to normalisation of bilirubin
    Description
    time to normalisation of bilirubin (in days)
    Time Frame
    first postoperative month
    Secondary Outcome Measure Information:
    Title
    Morbidity
    Description
    Morbidity as per Clavein Dindo classification
    Time Frame
    first postoperative month
    Title
    ICU stay
    Description
    Duration of ICU stay (in days)
    Time Frame
    first postoperative month
    Title
    Mortality
    Description
    death
    Time Frame
    first postoperative month
    Title
    Total hospital stay
    Description
    duration of total stay in hospital after liver transplantation (in days)
    Time Frame
    first postoperative month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients undergoing Living Donor Liver Transplantation(LDLT) accepted according to hospital protocol. Patients who have Portal Venous Pressure (PVP) > 15 mm Hg after reperfusion . Exclusion Criteria: Patients who have Portal Venous Pressure (PVP) > 15 mm Hg after reperfusion. Patients who had splenectomy. Patients who have splenic artery aneurysm.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdallah rashad
    Phone
    01015001867
    Email
    drabdallahtemerik@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26005570
    Citation
    Gad EH, Alsebaey A, Lotfy M, Eltabbakh M, Sherif AA. Complications and mortality after adult to adult living donor liver transplantation: A retrospective cohort study. Ann Med Surg (Lond). 2015 Apr 25;4(2):162-71. doi: 10.1016/j.amsu.2015.04.021. eCollection 2015 Jun.
    Results Reference
    background
    PubMed Identifier
    25593949
    Citation
    Abdeldayem H, Kashkoush S, Hegab BS, Aziz A, Shoreem H, Saleh S. Analysis of donor motivations in living donor liver transplantation. Front Surg. 2014 Jul 8;1:25. doi: 10.3389/fsurg.2014.00025. eCollection 2014. Erratum In: Front Surg. 2020 Jun 30;7:34.
    Results Reference
    background
    PubMed Identifier
    18791439
    Citation
    Umeda Y, Yagi T, Sadamori H, Matsukawa H, Matsuda H, Shinoura S, Mizuno K, Yoshida R, Iwamoto T, Satoh D, Tanaka N. Effects of prophylactic splenic artery modulation on portal overperfusion and liver regeneration in small-for-size graft. Transplantation. 2008 Sep 15;86(5):673-80. doi: 10.1097/TP.0b013e318181e02d.
    Results Reference
    background
    PubMed Identifier
    12717222
    Citation
    Ito T, Kiuchi T, Yamamoto H, Oike F, Ogura Y, Fujimoto Y, Hirohashi K, Tanaka AK. Changes in portal venous pressure in the early phase after living donor liver transplantation: pathogenesis and clinical implications. Transplantation. 2003 Apr 27;75(8):1313-7. doi: 10.1097/01.TP.0000063707.90525.10.
    Results Reference
    background
    PubMed Identifier
    19718645
    Citation
    Jiang SM, Zhou GW, Zhang R, Peng CH, Yan JQ, Wan L, Shen C, Chen H, Li QY, Shen BY, Li HW. Role of splanchnic hemodynamics in liver regeneration after living donor liver transplantation. Liver Transpl. 2009 Sep;15(9):1043-9. doi: 10.1002/lt.21797.
    Results Reference
    background
    PubMed Identifier
    12783396
    Citation
    Garcia-Valdecasas JC, Fuster J, Charco R, Bombuy E, Fondevila C, Ferrer J, Ayuso C, Taura P. Changes in portal vein flow after adult living-donor liver transplantation: does it influence postoperative liver function? Liver Transpl. 2003 Jun;9(6):564-9. doi: 10.1053/jlts.2003.50069.
    Results Reference
    background
    PubMed Identifier
    21542130
    Citation
    Wu TJ, Dahiya D, Lee CS, Lee CF, Chou HS, Chan KM, Lee WC. Impact of portal venous hemodynamics on indices of liver function and graft regeneration after right lobe living donor liver transplantation. Liver Transpl. 2011 Sep;17(9):1035-45. doi: 10.1002/lt.22326.
    Results Reference
    result

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    Impact of Splenic Artery Ligation in LDLT for Patients With Portal Hypertension

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