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

NCT ID: NCT04988100

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Living Donor Liver Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients who undergo Splenic artery ligation

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

Group Type EXPERIMENTAL

splenic artery ligation

Intervention Type PROCEDURE

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

No splenic artery ligation

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

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type PROCEDURE

Splenic artery is not ligated despite the presence of portal hyperperfusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

splenic artery ligation

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

Intervention Type PROCEDURE

No intervention

Splenic artery is not ligated despite the presence of portal hyperperfusion

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abdallah Rashad Abdelaziz

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Abdallah rashad

Role: CONTACT

01015001867

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 21542130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26005570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25593949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18791439 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12717222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19718645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12783396 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GIM in LDLT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.