Doppler Ultrasonography in Assessment of Graft Hemodynamics After Living-Donor Liver Transplantation

Liver Transplant, Complications Clinical Trial

Official title:

Doppler Ultrasonography in Assessment of Graft Hemodynamics After Living-Donor Liver Transplantation in Al-Rajhi Liver Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03893773
• Other study ID #: DAGHALDLTAL
• Status: Not yet recruiting
• Start date: April 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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% 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 .

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults more than 18 y with living donor liver transplantation in Al-Rajhi liver hospital, Assiut, Egypt

Exclusion Criteria:

• Pediatric liver transplantation

Related Conditions & MeSH terms

• Liver Transplant, Complications

Intervention

Device:
• doppler ultrasonagraphy
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ZRMohamed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of vascular complication:	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).	6 month after liver transplantation.
Primary	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).	6 month after liver transplantation