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

Living Donor Liver Transplantation Clinical Trial

Official title:

Impact of Splenic Artery Ligation in Living Donor Liver Transplantation for Patients With Portal Hypertension on Early Graft Function.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04988100
• Other study ID #: GIM in LDLT
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: August 2021
• Source: Assiut University
• Contact: Abdallah rashad
• Phone: 01015001867
• Email: drabdallahtemerik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Living Donor Liver Transplantation

Intervention

Procedure:
• splenic artery ligation
Splenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas
• No intervention
Splenic artery is not ligated despite the presence of portal hyperperfusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

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. — View 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. — View Citation

García-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. — View 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. — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of early graft dysfunction	Number of patients who develop early graft dysfunction in each group	first postoperative month
Primary	Time to normalisation of ascites output	time to normalisation of ascites output (in days)	first postoperative month
Primary	Time to normalisation of INR	time to normalisation of INR (in days)	first postoperative month
Primary	Time to normalisation of bilirubin	time to normalisation of bilirubin (in days)	first postoperative month
Secondary	Morbidity	Morbidity as per Clavein Dindo classification	first postoperative month
Secondary	ICU stay	Duration of ICU stay (in days)	first postoperative month
Secondary	Mortality	death	first postoperative month
Secondary	Total hospital stay	duration of total stay in hospital after liver transplantation (in days)	first postoperative month