Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT05132192
Status:
COMPLETED
Last Update Posted:
2021-11-24
First Post:
2021-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis
Sponsor:
Elvan Onur Kirimker
Organization:
Study Overview
Official Title:
Outcomes of Surgical Strategies for Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Data of demographic, clinical, laboratory and imaging studies of living donor liver transplantation (LDLT) recipients from two transplant centers were collected. Survival and morbidity rates between patients with and without portal vein thrombosis (PVT) were compared. Risk factors of mortality in the setting of PVT were identified. Intraoperative portal flow measurements were compared before and after portal flow restoration.
Detailed Description:
LDLTs performed in two experienced centers (Ankara University Ibn-i Sina Hospital and Ankara Güven Hospital) between January 2013 and February 2020 were evaluated and included in the cohort study. Deceased donor liver transplants and pediatric transplants (deceased or living) were excluded from the study.
Data relating to this study including patient history, preoperative laboratory and imaging test results, reports of surgical procedures or interventions, intraoperative anesthesia records, post-operative laboratory trends, and postoperative complications were extracted from the computer-based data management system and prospectively maintained in transplant databases in both centers. Recipients of LDLT were divided in two groups according to the presence or absence of PVT.
Portal flow measurements were recorded with VeriQ (Medistim ASA, Oslo, Norway) Doppler flowmeter device in one of the centers later in the study period.
The follow-up and recordings of the patients were maintained in the outpatient clinics of the two centers.
The most serious complication experienced by each patient was recorded according to the Clavien-Dindo classification Primary outcome of the current study was the survival rates of patients with and without PVT Secondary outcomes of the study included morbidity in patients with and without PVT after LDLT, risk factors of mortality after LDLT to patients with PVT and comparison of intraoperative portal flow measurements between patients with and without PVT
Data relating to this study including patient history, preoperative laboratory and imaging test results, reports of surgical procedures or interventions, intraoperative anesthesia records, post-operative laboratory trends, and postoperative complications were extracted from the computer-based data management system and prospectively maintained in transplant databases in both centers. Recipients of LDLT were divided in two groups according to the presence or absence of PVT.
Portal flow measurements were recorded with VeriQ (Medistim ASA, Oslo, Norway) Doppler flowmeter device in one of the centers later in the study period.
The follow-up and recordings of the patients were maintained in the outpatient clinics of the two centers.
The most serious complication experienced by each patient was recorded according to the Clavien-Dindo classification Primary outcome of the current study was the survival rates of patients with and without PVT Secondary outcomes of the study included morbidity in patients with and without PVT after LDLT, risk factors of mortality after LDLT to patients with PVT and comparison of intraoperative portal flow measurements between patients with and without PVT
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: