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

August 14, 2021 updated by: Abdallah Rashad Abdelaziz, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients who undergo Splenic artery ligation
If inclusion criteria are met, these group of patients will undergo splenic artery ligation .
Procedure: splenic artery ligation
Splenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas
Active Comparator: No splenic artery ligation
If inclusion criteria are met, these group of patients will not undergo splenic artery ligation.
Procedure: No intervention
Splenic artery is not ligated despite the presence of portal hyperperfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of early graft dysfunction
Time Frame: first postoperative month
Number of patients who develop early graft dysfunction in each group
first postoperative month
Time to normalisation of ascites output
Time Frame: first postoperative month
time to normalisation of ascites output (in days)
first postoperative month
Time to normalisation of INR
Time Frame: first postoperative month
time to normalisation of INR (in days)
first postoperative month
Time to normalisation of bilirubin
Time Frame: first postoperative month
time to normalisation of bilirubin (in days)
first postoperative month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: first postoperative month
death
first postoperative month
Morbidity
Time Frame: first postoperative month
Morbidity as per Clavein Dindo classification
first postoperative month
ICU stay
Time Frame: first postoperative month
Duration of ICU stay (in days)
first postoperative month
Total hospital stay
Time Frame: first postoperative month
duration of total stay in hospital after liver transplantation (in days)
first postoperative month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

July 25, 2021

First Submitted That Met QC Criteria

July 25, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 14, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIM in LDLT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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