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

NCT04988100 | Unknown

• 1 other identifier: GIM in LDLT
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Living Donor Liver Transplantation

Outcome Measures

Primary Outcomes (4)

• Incidence of early graft dysfunction

  Number of patients who develop early graft dysfunction in each group

  first postoperative month

• Time to normalisation of ascites output

  time to normalisation of ascites output (in days)

  first postoperative month

• Time to normalisation of INR

  time to normalisation of INR (in days)

  first postoperative month

• Time to normalisation of bilirubin

  time to normalisation of bilirubin (in days)

  first postoperative month

Secondary Outcomes (4)

• Morbidity

  first postoperative month

• ICU stay

  first postoperative month

• Mortality

  first postoperative month

• Total hospital stay

  first postoperative month

Study Arms (2)

Patients who undergo Splenic artery ligation

EXPERIMENTAL

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

Procedure: splenic artery ligation

No splenic artery ligation

ACTIVE COMPARATOR

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

Procedure: No intervention

Interventions

splenic artery ligation PROCEDURE

Splenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas

Patients who undergo Splenic artery ligation

No intervention PROCEDURE

Splenic artery is not ligated despite the presence of portal hyperperfusion

No splenic artery ligation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 26005570 BACKGROUND

• 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.

  PMID: 25593949 BACKGROUND

• 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.

  PMID: 18791439 BACKGROUND

• 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.

  PMID: 12717222 BACKGROUND

• 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.

  PMID: 19718645 BACKGROUND

• 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.

  PMID: 12783396 BACKGROUND

• 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.

  PMID: 21542130 RESULT

Central Study Contacts

Abdallah rashad

CONTACT

01015001867; drabdallahtemerik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: August 3, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 17, 2021

Record last verified: 2021-08