Clinical trial NCT04988100: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Living Donor Liver Transplantation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Primary outcomes:
measure: Incidence of early graft dysfunction
timeFrame: first postoperative month
measure: Time to normalisation of ascites output
timeFrame: first postoperative month
measure: Time to normalisation of INR
timeFrame: first postoperative month
measure: Time to normalisation of bilirubin
timeFrame: first postoperative month
Secondary outcomes:
measure: Morbidity
timeFrame: first postoperative month
measure: ICU stay
timeFrame: first postoperative month
measure: Mortality
timeFrame: first postoperative month
measure: Total hospital stay
timeFrame: first postoperative month
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.