Liver TransplantationNCT07192653
Intraoperative Endovascular Treatment Via the Ligamentum Teres Hepatis in Liver Transplantation for Yerdel Grade Ⅲ/IV Portal Vein Thrombosis: A Safe and Effective Strategy
An observational study of Liver Transplantation and Endovascular Treatment, run by Chiyi Chen.
Trial summary
Background: To evaluate the safety and efficacy of intraoperative endovascular treatment (EVT) using the donor ligamentum teres hepatis (LTH) approach for Yerdel grade III/IV portal vein thrombosis (PVT) during liver transplantation (LT), a condition that poses a major challenge in complex surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Endovascular Treatment
- What is being tested?
- nonanatomical anastomosis and LTH-based EVT
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Apr 2025
- 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: Conducted a retrospective cohort analysis of 1,478 consecutive adult patients (aged ≥18 years) who underwent deceased-donor liver transplantation at Tianjin First Central Hospital between February 2016 and December 2024.From this population, the investigators identified 75 recipients with Yerdel grade III/IV PVT, which was confirmed by multiphase contrast-enhanced CT, indirect portography, and intraoperative evaluation. Exclusion criteria were living-donor and split-liver procedures. All procedures were performed using classic orthotopic transplantations. To evaluate the evolution of our PVT management strategy, the investigators divided the cohort into two chronologically distinct periods: period 1 (pre-intervention): February 2016-January 2019 (n=41), and period 2 (LTH protocol): February 2019-December 2024 (n=34).
Who may be able to join
- Adult patients (aged ≥18 years).
- Patients underwent deceased-donor liver transplantation.
- At Tianjin First Central Hospital between February 2016 and December 2024.
- Identified recipients with Yerdel grade III/IV PVT, which was confirmed by multiphase contrast-enhanced CT, indirect portography, and intraoperative evaluation
Who cannot join
- Exclusion criteria were living-donor and split-liver procedures.
- All procedures were performed using classic orthotopic transplantations.
About this study
Background: To evaluate the safety and efficacy of intraoperative endovascular treatment (EVT) using the donor ligamentum teres hepatis (LTH) approach for Yerdel grade III/IV portal vein thrombosis (PVT) during liver transplantation (LT), a condition that poses a major challenge in complex surgeries.
Methods: This single-center retrospective cohort study included some patients with grade III/IV PVT who underwent LT and were divided into two periods: in both periods, patients underwent modified eversion thrombectomy. However, in Period 1 (2016-2019), nonanatomical anastomosis was performed if portal flow was insufficient, and in Period 2 (2019-2024), patients with persistent hypoperfusion underwent additional LTH-based EVT (stenting or shunt occlusion). Perioperative outcomes (operative time, anhepatic phase, and anastomosis type) and long-term outcomes (graft survival and complication rates) were compared between groups.
- Conditions
- Liver Transplantation, Endovascular Treatment
- Being tested
- nonanatomical anastomosis, LTH-based EVT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonanatomical anastomosisProcedure or surgery
In Period 1 (2016-2019, n=41), nonanatomical anastomosis was performed if portal flow was insufficient.
LTH-based EVTProcedure or surgery
In Period 2 (2019-2024, n=34), patients with persistent hypoperfusion underwent additional LTH-based EVT (stenting or shunt occlusion)
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Not described Receives: Procedure: nonanatomical anastomosis | |
| Period 2 | Not described Receives: Procedure: LTH-based EVT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Operative time refers to the duration from the initial surgical incision to the completion of skin closure.
Measured: Intraoperative
Anhepatic Phase Time
The anhepatic phase time is the critical period during liver transplant surgery when the patient's native liver has been removed and the donor liver has not yet been reperfused.
Measured: Intraoperative
Rate of Nonanatomical Reconstruction
The rate of nonanatomical resection refers to the frequency with which a surgical procedure removes a tumor without following the boundaries of the organ's functional anatomical units.
Measured: Intraoperative
Delayed Graft Function
Delayed graft function is a common complication following kidney transplantation where the transplanted organ does not function immediately, often necessitating dialysis within the first week post-surgery.
Measured: Within 7 days postoperatively
Portal Vein Complications
Portal vein complications are a serious concern in liver transplantation, encompassing issues such as thrombosis, stenosis, and occlusion that can threaten graft survival and patient life.
Measured: From the surgery to the last follow-up (median follow-up 28 months)
Graft Survival
Graft survival refers to the continued functional existence of a transplanted organ or tissue within a recipient's body.
Measured: 1-year and 3-year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study startFeb 2016
- Primary completionDec 2024
- Study completionApr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiyi Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chiyi Chen, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192653
- Sponsor's protocol ID
- ChenC
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Endovascular Treatment Via the Ligamentum Teres Hepatis in Liver Transplantation for Yerdel Grade Ⅲ/IV Portal Vein Thrombosis: A Safe and Effective Strategy
- ClinicalTrials.gov ID
- NCT07192653
- Acronym / sponsor ID
- ChenC
- Conditions
- Liver Transplantation, Endovascular Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Chiyi ChenUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Apr 2025 (actual)
- First posted
- 25 Sep 2025 (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.
Background: To evaluate the safety and efficacy of intraoperative endovascular treatment (EVT) using the donor ligamentum teres hepatis (LTH) approach for Yerdel grade III/IV portal vein thrombosis (PVT) during liver transplantation (LT), a condition that poses a major challenge in complex surgeries.
Methods: This single-center retrospective cohort study included some patients with grade III/IV PVT who underwent LT and were divided into two periods: in both periods, patients underwent modified eversion thrombectomy. However, in Period 1 (2016-2019), nonanatomical anastomosis was performed if portal flow was insufficient, and in Period 2 (2019-2024), patients with persistent hypoperfusion underwent additional LTH-based EVT (stenting or shunt occlusion). Perioperative outcomes (operative time, anhepatic phase, and anastomosis type) and long-term outcomes (graft survival and complication rates) were compared between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 | – | Procedure: nonanatomical anastomosis |
| Period 2 | – | Procedure: LTH-based EVT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Conducted a retrospective cohort analysis of 1,478 consecutive adult patients (aged ≥18 years) who underwent deceased-donor liver transplantation at Tianjin First Central Hospital between February 2016 and December 2024.From this population, the investigators identified 75 recipients with Yerdel grade III/IV PVT, which was confirmed by multiphase contrast-enhanced CT, indirect portography, and intraoperative evaluation. Exclusion criteria were living-donor and split-liver procedures. All procedures were performed using classic orthotopic transplantations. To evaluate the evolution of our PVT management strategy, the investigators divided the cohort into two chronologically distinct periods: period 1 (pre-intervention): February 2016-January 2019 (n=41), and period 2 (LTH protocol): February 2019-December 2024 (n=34).
Key inclusion criteria (4 listed)
- Adult patients (aged ≥18 years).
- Patients underwent deceased-donor liver transplantation.
- At Tianjin First Central Hospital between February 2016 and December 2024.
- Identified recipients with Yerdel grade III/IV PVT, which was confirmed by multiphase contrast-enhanced CT, indirect portography, and intraoperative evaluation
Key exclusion criteria (2 listed)
- Exclusion criteria were living-donor and split-liver procedures.
- All procedures were performed using classic orthotopic transplantations.
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 |
|---|---|---|
| nonanatomical anastomosisIn Period 1 (2016-2019, n=41), nonanatomical anastomosis was performed if portal flow was insufficient. | Procedure or surgery | Period 1 |
| LTH-based EVTIn Period 2 (2019-2024, n=34), patients with persistent hypoperfusion underwent additional LTH-based EVT (stenting or shunt occlusion) | Procedure or surgery | Period 2 |
Primary outcome
Operative Time
Time frame: Intraoperative
Operative time refers to the duration from the initial surgical incision to the completion of skin closure.
Anhepatic Phase Time
Time frame: Intraoperative
The anhepatic phase time is the critical period during liver transplant surgery when the patient's native liver has been removed and the donor liver has not yet been reperfused.
Rate of Nonanatomical Reconstruction
Time frame: Intraoperative
The rate of nonanatomical resection refers to the frequency with which a surgical procedure removes a tumor without following the boundaries of the organ's functional anatomical units.
Delayed Graft Function
Time frame: Within 7 days postoperatively
Delayed graft function is a common complication following kidney transplantation where the transplanted organ does not function immediately, often necessitating dialysis within the first week post-surgery.
Portal Vein Complications
Time frame: From the surgery to the last follow-up (median follow-up 28 months)
Portal vein complications are a serious concern in liver transplantation, encompassing issues such as thrombosis, stenosis, and occlusion that can threaten graft survival and patient life.
Graft Survival
Time frame: 1-year and 3-year postoperatively
Graft survival refers to the continued functional existence of a transplanted organ or tissue within a recipient's body.
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 25 Sep 2025.
- Individual participant dataSharing planned: No
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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.
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 Transplantation and Endovascular Treatment, run by Chiyi Chen.
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 4 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 25 Sep 2025. 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?
Operative Time (time frame: Intraoperative). The study lists 6 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 25 Sep 2025.