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
About this trial
This is an interventional treatment trial for Living Donor Liver Transplantation
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.
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
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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