Liver Transplant, ComplicationsNCT03893773
Doppler Ultrasonography in Assessment of Graft Hemodynamics After Living-Donor Liver Transplantation
An observational study of Liver Transplant, Complications, run by ZRMohamed.
Trial summary
Graft ischemia after liver transplantation is associated with a high incidence of morbidity and mortality . The overall incidence of vascular complications in adults varies widely among transplant centers worldwide, but remains around 7% in various series of deceased donor liver transplantation (DDLT), and around 13%… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplant, Complications
- What is being tested?
- doppler ultrasonagraphy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 30 Jun 2021
- Phase
- Observational
- 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
Study population: Adults more than 18 y with living donor liver transplantation in Al-Rajhi liver hospital, Assiut, Egypt
Who may be able to join
- Adults more than 18 y with living donor liver transplantation in Al-Rajhi liver hospital, Assiut, Egypt
Who cannot join
- Pediatric liver transplantation
About this study
Official title: Doppler Ultrasonography in Assessment of Graft Hemodynamics After Living-Donor Liver Transplantation in Al-Rajhi Liver Hospital
Graft ischemia after liver transplantation is associated with a high incidence of morbidity and mortality . The overall incidence of vascular complications in adults varies widely among transplant centers worldwide, but remains around 7% in various series of deceased donor liver transplantation (DDLT), and around 13% involving living donor liver transplantation (LDLT) Vascular complications include; hepatic artery thrombosis and stenosis, portal vein thrombosis and stenosis, caval and hepatic veins obstruction, arterial pseudo aneurysm. Biliary complications include; biliary leakage, stricture and obstruction .
Read the detailed description
Hepatic artery thrombosis (HAT) is the most severe and frequent complication represents more than 50% of all arterial complications. Early HAT occurring within 1 month post-operation in 2.9%, and late HAT in 2.2%. The overall mortality rate for patients with early HAT is about 33% (13).
Hepatic arterial stenosis can occur immediately postoperative or later with an incidence of 1% to 2% and has been suggested to progress to HAT. This is due to surgical technique or fibrotic healing (14).
Hepatic artery aneurysm or pseudoaneurysm is rare and has an incidence of 0.27-3%. They occur in the second or third post-transplant week after infection caused by biliary sepsis, intestinal perforation, anastomotic leak, or intrahepatic stenting, or technical failure .
Portal vein thrombosis (partial or complete) or stenosis has an incidence of 2-3%, it can occur early postoperative within 1 month or more late. Early portal vein thrombosis can lead to liver insufficiency and failure. Late presentation, depending on the collateral circulation, can lead to portal hypertension with varices and ascites .
Currently, transplant outflow obstruction by kinking, stenosis or thrombosis of the inferior vena cava (IVC) or hepatic vein, especially in LDLT, are relatively uncommon complications following liver transplantation with an reported incidence of less than 3%. The main risk factor is a technical error in the creation of the anastomosis Despite all the advances in transplant patient care and surgical techniques, biliary complications remain high incidence in living donor or split liver transplant. There are early and late complications, and there are anastomotic, and nonanastomotic biliary complications, such as stones, sludge and casts .
- Conditions
- Liver Transplant, Complications
- Being tested
- doppler ultrasonagraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doppler ultrasonagraphyDevice
The following parameters will be measured:
Hepatic artery Resistance index (HARI), Diameter, peak systolic velocity (HAPSV, cm/s).
Portal vein peak velocity (PVPV) and diameter at the anastomotic and non-anastomotic sites.
Hepatic vein peak velocity and wave form
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vascular complication:
- Hepatic artery thrombosis (HAT), stenosis (HAS). B. Portal vein thrombosis (PVT), or stenosis. C. Hepatic veins and inferior vena cava thrombosis, or stenosis. The investigator will record nature of the complication, time of presentation and Number of hospital re-admissions (due to vascular complications).
Measured: 6 month after liver transplantation.
Intervention done due to vascular complication
Non-surgical intervention (percutaneous transluminal angioplasty (PTA) +/- stent placement, catheter-directed thrombolysis, thrombectomy, trans-catheter arterial embolization) or surgical revision with detailed description of each intervention and if the intervention is successful or not (improvement of symptom and liver function).
Measured: 6 month after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant, ComplicationsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZRMohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ZRMohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893773
- Sponsor's protocol ID
- DAGHALDLTAL
- Status last verified
- Mar 2019
- First submitted
- 24 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler Ultrasonography in Assessment of Graft Hemodynamics After Living-Donor Liver Transplantation in Al-Rajhi Liver Hospital
- ClinicalTrials.gov ID
- NCT03893773
- Acronym / sponsor ID
- DAGHALDLTAL
- Conditions
- Liver Transplant, Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ZRMohamedUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 28 Mar 2019 (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.
Graft ischemia after liver transplantation is associated with a high incidence of morbidity and mortality . The overall incidence of vascular complications in adults varies widely among transplant centers worldwide, but remains around 7% in various series of deceased donor liver transplantation (DDLT), and around 13% involving living donor liver transplantation (LDLT) Vascular complications include; hepatic artery thrombosis and stenosis, portal vein thrombosis and stenosis, caval and hepatic veins obstruction, arterial pseudo aneurysm. Biliary complications include; biliary leakage, stricture and obstruction .
Detailed description
Hepatic artery thrombosis (HAT) is the most severe and frequent complication represents more than 50% of all arterial complications. Early HAT occurring within 1 month post-operation in 2.9%, and late HAT in 2.2%. The overall mortality rate for patients with early HAT is about 33% (13).
Hepatic arterial stenosis can occur immediately postoperative or later with an incidence of 1% to 2% and has been suggested to progress to HAT. This is due to surgical technique or fibrotic healing (14).
Hepatic artery aneurysm or pseudoaneurysm is rare and has an incidence of 0.27-3%. They occur in the second or third post-transplant week after infection caused by biliary sepsis, intestinal perforation, anastomotic leak, or intrahepatic stenting, or technical failure .
Portal vein thrombosis (partial or complete) or stenosis has an incidence of 2-3%, it can occur early postoperative within 1 month or more late. Early portal vein thrombosis can lead to liver insufficiency and failure. Late presentation, depending on the collateral circulation, can lead to portal hypertension with varices and ascites .
Currently, transplant outflow obstruction by kinking, stenosis or thrombosis of the inferior vena cava (IVC) or hepatic vein, especially in LDLT, are relatively uncommon complications following liver transplantation with an reported incidence of less than 3%. The main risk factor is a technical error in the creation of the anastomosis Despite all the advances in transplant patient care and surgical techniques, biliary complications remain high incidence in living donor or split liver transplant. There are early and late complications, and there are anastomotic, and nonanastomotic biliary complications, such as stones, sludge and casts .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults more than 18 y with living donor liver transplantation in Al-Rajhi liver hospital, Assiut, Egypt
Key inclusion criteria (1 listed)
- Adults more than 18 y with living donor liver transplantation in Al-Rajhi liver hospital, Assiut, Egypt
Key exclusion criteria (1 listed)
- Pediatric liver transplantation
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 |
|---|---|---|
| doppler ultrasonagraphyThe following parameters will be measured: Hepatic artery Resistance index (HARI), Diameter, peak systolic velocity (HAPSV, cm/s). Portal vein peak velocity (PVPV) and diameter at the anastomotic and non-anastomotic sites. Hepatic vein peak velocity and wave form | Device | – |
Primary outcome
Incidence of vascular complication:
Time frame: 6 month after liver transplantation.
A. Hepatic artery thrombosis (HAT), stenosis (HAS). B. Portal vein thrombosis (PVT), or stenosis. C. Hepatic veins and inferior vena cava thrombosis, or stenosis. The investigator will record nature of the complication, time of presentation and Number of hospital re-admissions (due to vascular complications).
Intervention done due to vascular complication
Time frame: 6 month after liver transplantation
Non-surgical intervention (percutaneous transluminal angioplasty (PTA) +/- stent placement, catheter-directed thrombolysis, thrombectomy, trans-catheter arterial embolization) or surgical revision with detailed description of each intervention and if the intervention is successful or not (improvement of symptom and liver function).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
Related trials for Liver Transplant, Complications
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant, Complications, run by ZRMohamed.
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 1 inclusion and 1 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 28 Mar 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of vascular complication: (time frame: 6 month after liver transplantation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2019.