Living Donor Liver TransplantationNCT04988100
Impact of Splenic Artery Ligation in LDLT for Patients With Portal Hypertension
A study testing splenic artery ligation in people with Living Donor Liver Transplantation, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Living Donor Liver Transplantation
- What is being tested?
- splenic artery ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- Patients who have Portal Venous Pressure (PVP) > 15 mm Hg after reperfusion.
- Patients who had splenectomy.
- Patients who have splenic artery aneurysm.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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 .
- Conditions
- Living Donor Liver Transplantation
- Being tested
- splenic artery ligation, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
splenic artery ligationProcedure or surgery
Splenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas
No interventionProcedure or surgery
Splenic artery is not ligated despite the presence of portal hyperperfusion
| Study group | Role | What they receive |
|---|---|---|
| Patients who undergo Splenic artery ligation | Experimental | If inclusion criteria are met, these group of patients will undergo splenic artery ligation . Receives: 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. Receives: Procedure: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of early graft dysfunction
Number of patients who develop early graft dysfunction in each group
Measured: first postoperative month
Time to normalisation of ascites output
time to normalisation of ascites output (in days)
Measured: first postoperative month
Time to normalisation of INR
time to normalisation of INR (in days)
Measured: first postoperative month
Time to normalisation of bilirubin
time to normalisation of bilirubin (in days)
Measured: first postoperative month
Secondary outcomes (4)
Morbidity
Morbidity as per Clavein Dindo classification
Measured: first postoperative month
ICU stay
Duration of ICU stay (in days)
Measured: first postoperative month
Mortality
death
Measured: first postoperative month
Total hospital stay
duration of total stay in hospital after liver transplantation (in days)
Measured: first postoperative month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Living Donor Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Rashad Abdelaziz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988100
- Sponsor's protocol ID
- GIM in LDLT
- Status last verified
- Aug 2021
- First submitted
- 25 Jul 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26005570Abdeldayem 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.
PubMed 25593949Umeda 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.
PubMed 18791439Ito 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.
PubMed 12717222Jiang 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.
PubMed 19718645Garcia-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.
PubMed 12783396Wu 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.
PubMed 21542130
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Splenic Artery Ligation in Living Donor Liver Transplantation for Patients With Portal Hypertension on Early Graft Function.
- ClinicalTrials.gov ID
- NCT04988100
- Acronym / sponsor ID
- GIM in LDLT
- Conditions
- Living Donor Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who undergo Splenic artery ligation | Experimental | Procedure: splenic artery ligationIf inclusion criteria are met, these group of patients will undergo splenic artery ligation . |
| No splenic artery ligation | Active comparator | Procedure: No interventionIf inclusion criteria are met, these group of patients will not undergo splenic artery ligation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 .
Key exclusion criteria (3 listed)
- Patients who have Portal Venous Pressure (PVP) > 15 mm Hg after reperfusion.
- Patients who had splenectomy.
- Patients who have splenic artery aneurysm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| splenic artery ligationSplenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas | Procedure or surgery | Patients who undergo Splenic artery ligation |
| No interventionSplenic artery is not ligated despite the presence of portal hyperperfusion | Procedure or surgery | No splenic artery ligation |
Primary outcome
Incidence of early graft dysfunction
Time frame: first postoperative month
Number of patients who develop early graft dysfunction in each group
Time to normalisation of ascites output
Time frame: first postoperative month
time to normalisation of ascites output (in days)
Time to normalisation of INR
Time frame: first postoperative month
time to normalisation of INR (in days)
Time to normalisation of bilirubin
Time frame: first postoperative month
time to normalisation of bilirubin (in days)
4 secondary outcomes
Morbidity
Time frame: first postoperative month
ICU stay
Time frame: first postoperative month
Mortality
Time frame: first postoperative month
Total hospital stay
Time frame: first postoperative month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Background: PubMed 26005570Gad 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.
- Background: PubMed 25593949Abdeldayem 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.
- Background: PubMed 18791439Umeda 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.
- Background: PubMed 12717222Ito 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.
- Background: PubMed 19718645Jiang 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.
- Background: PubMed 12783396Garcia-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.
- Results publication: PubMed 21542130Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing splenic artery ligation in people with Living Donor Liver Transplantation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdallah rashad (01015001867, drabdallahtemerik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of early graft dysfunction (time frame: first postoperative month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988100, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.