Portal Vein ThrombosisNCT05132192
Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis
An observational study of Portal Vein Thrombosis and Liver Transplant; Complications, run by Elvan Onur Kirimker.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Vein Thrombosis, Liver Transplant; Complications
- What is being tested?
- living donor liver transplantation and Thrombectomy or interposition graft
- Type of treatment
- Surgery or procedure
- How many people
- 335 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 30 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients that who underwent living donor liver transplantation in the study period in the two centers
Who may be able to join
- Patients underwent liver transplantation
Who cannot join
- Pediatric liver transplants
- Deceased donor liver transplants
About this study
Official title: Outcomes of Surgical Strategies for Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis
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.
Read the 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
- Being tested
- living donor liver transplantation, Thrombectomy or interposition graft
- Keywords
- Liver transplantation, Portal vein thrombosis, Thrombectomy, Doppler flowmeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
living donor liver transplantationProcedure or surgery
Living donor liver transplantation
Thrombectomy or interposition graftProcedure or surgery
Portal flow restoration due to PVT in any manner
| Study group | Role | What they receive |
|---|---|---|
| PVT | Patients with pretransplant portal vein thrombosis Receives: Procedure: living donor liver transplantation; Procedure: Thrombectomy or interposition graft | |
| non-PVT | Patients without pretransplant portal vein thrombosis Receives: Procedure: living donor liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Posttransplant survival time
Measured: Time (days) from post transplant day1 to post transplant1 year
Secondary outcomes (2)
Complications
Highest grade of complication after LDLT according to Dindo-Clavien Classification
Measured: From posttransplant day1 to post-transplant 30th day
Flow
Intraoperative portal flow measurements (ml/min) of diseased liver and transplanted liver with Doppler flowmeter
Measured: Intraoperatively twice: before recipient hepatectomy (portal flow of diseased liver ) and at the end of transplantation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Jan 2013
- Primary completion30 Jul 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Portal Vein ThrombosisStudies 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
- Retrospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elvan Onur Kirimker
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University, Ankara Guven Hospital
- Responsible party
- Sponsor-investigator, Elvan Onur Kirimker, Ankara University
- Investigators
- Elvan O Kirimker, MD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132192
- Sponsor's protocol ID
- PVT-LDLT-ANK
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared
Publications
Conzen KD, Pomfret EA. Liver transplant in patients with portal vein thrombosis: Medical and surgical requirements. Liver Transpl. 2017 Oct;23(S1):S59-S63. doi: 10.1002/lt.24856. No abstract available.
PubMed 28834305Yerdel MA, Gunson B, Mirza D, Karayalcin K, Olliff S, Buckels J, Mayer D, McMaster P, Pirenne J. Portal vein thrombosis in adults undergoing liver transplantation: risk factors, screening, management, and outcome. Transplantation. 2000 May 15;69(9):1873-81. doi: 10.1097/00007890-200005150-00023.
PubMed 10830225Ravaioli M, Zanello M, Grazi GL, Ercolani G, Cescon M, Del Gaudio M, Cucchetti A, Pinna AD. Portal vein thrombosis and liver transplantation: evolution during 10 years of experience at the University of Bologna. Ann Surg. 2011 Feb;253(2):378-84. doi: 10.1097/SLA.0b013e318206818b.
PubMed 21183851Zanetto A, Rodriguez-Kastro KI, Germani G, Ferrarese A, Cillo U, Burra P, Senzolo M. Mortality in liver transplant recipients with portal vein thrombosis - an updated meta-analysis. Transpl Int. 2018 Dec;31(12):1318-1329. doi: 10.1111/tri.13353. Epub 2018 Oct 23.
PubMed 30230053Qi X, Dai J, Jia J, Ren W, Yang M, Li H, Fan D, Guo X. Association between portal vein thrombosis and survival of liver transplant recipients: a systematic review and meta-analysis of observational studies. J Gastrointestin Liver Dis. 2015 Mar;24(1):51-9, 4 p following 59. doi: 10.15403/jgld.2014.1121.qix.
PubMed 25822434Hibi T, Nishida S, Levi DM, Selvaggi G, Tekin A, Fan J, Ruiz P, Tzakis AG. When and why portal vein thrombosis matters in liver transplantation: a critical audit of 174 cases. Ann Surg. 2014 Apr;259(4):760-6. doi: 10.1097/SLA.0000000000000252.
PubMed 24299686
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Surgical Strategies for Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis
- ClinicalTrials.gov ID
- NCT05132192
- Acronym / sponsor ID
- PVT-LDLT-ANK
- Keywords
- Liver transplantation, Portal vein thrombosis, Thrombectomy, Doppler flowmeter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Elvan Onur KirimkerUniversity, hospital or other
- Collaborators
- Ankara University, Ankara Guven Hospital
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 24 Nov 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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVT | – | Procedure: living donor liver transplantation, Procedure: Thrombectomy or interposition graftPatients with pretransplant portal vein thrombosis |
| non-PVT | – | Procedure: living donor liver transplantationPatients without pretransplant portal vein thrombosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients that who underwent living donor liver transplantation in the study period in the two centers
Key inclusion criteria (1 listed)
- Patients underwent liver transplantation
Key exclusion criteria (2 listed)
- Pediatric liver transplants
- Deceased donor liver transplants
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 |
|---|---|---|
| living donor liver transplantationLiving donor liver transplantation | Procedure or surgery | PVT, non-PVT |
| Thrombectomy or interposition graftPortal flow restoration due to PVT in any manner | Procedure or surgery | PVT |
Primary outcome
Survival
Time frame: Time (days) from post transplant day1 to post transplant1 year
Posttransplant survival time
2 secondary outcomes
Complications
Time frame: From posttransplant day1 to post-transplant 30th day
Flow
Time frame: Intraoperatively twice: before recipient hepatectomy (portal flow of diseased liver ) and at the end of transplantation procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Background: PubMed 28834305Conzen KD, Pomfret EA. Liver transplant in patients with portal vein thrombosis: Medical and surgical requirements. Liver Transpl. 2017 Oct;23(S1):S59-S63. doi: 10.1002/lt.24856. No abstract available.
- Background: PubMed 10830225Yerdel MA, Gunson B, Mirza D, Karayalcin K, Olliff S, Buckels J, Mayer D, McMaster P, Pirenne J. Portal vein thrombosis in adults undergoing liver transplantation: risk factors, screening, management, and outcome. Transplantation. 2000 May 15;69(9):1873-81. doi: 10.1097/00007890-200005150-00023.
- Background: PubMed 21183851Ravaioli M, Zanello M, Grazi GL, Ercolani G, Cescon M, Del Gaudio M, Cucchetti A, Pinna AD. Portal vein thrombosis and liver transplantation: evolution during 10 years of experience at the University of Bologna. Ann Surg. 2011 Feb;253(2):378-84. doi: 10.1097/SLA.0b013e318206818b.
- Background: PubMed 30230053Zanetto A, Rodriguez-Kastro KI, Germani G, Ferrarese A, Cillo U, Burra P, Senzolo M. Mortality in liver transplant recipients with portal vein thrombosis - an updated meta-analysis. Transpl Int. 2018 Dec;31(12):1318-1329. doi: 10.1111/tri.13353. Epub 2018 Oct 23.
- Background: PubMed 25822434Qi X, Dai J, Jia J, Ren W, Yang M, Li H, Fan D, Guo X. Association between portal vein thrombosis and survival of liver transplant recipients: a systematic review and meta-analysis of observational studies. J Gastrointestin Liver Dis. 2015 Mar;24(1):51-9, 4 p following 59. doi: 10.15403/jgld.2014.1121.qix.
- Background: PubMed 24299686Hibi T, Nishida S, Levi DM, Selvaggi G, Tekin A, Fan J, Ruiz P, Tzakis AG. When and why portal vein thrombosis matters in liver transplantation: a critical audit of 174 cases. Ann Surg. 2014 Apr;259(4):760-6. doi: 10.1097/SLA.0000000000000252.
- Individual participant dataSharing planned: No. Data will not be shared
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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.
Elvan O Kirimker, MD principal investigator
Ankara University
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Vein Thrombosis and Liver Transplant; Complications, run by Elvan Onur Kirimker.
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 2 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: finished, as of the sponsor's last update on 24 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival (time frame: Time (days) from post transplant day1 to post transplant1 year). 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 NCT05132192, which also lists 6 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 24 Nov 2021.