NCT07192653

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

8.8 years

First QC Date

September 10, 2025

Last Update Submit

September 17, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Operative Time

    Operative time refers to the duration from the initial surgical incision to the completion of skin closure.

    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.

    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.

    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.

    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.

    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.

    1-year and 3-year postoperatively

Study Arms (2)

Period 1

Procedure: nonanatomical anastomosis

Period 2

Procedure: LTH-based EVT

Interventions

In Period 1 (2016-2019, n=41), nonanatomical anastomosis was performed if portal flow was insufficient.

Period 1
LTH-based EVTPROCEDURE

In Period 2 (2019-2024, n=34), patients with persistent hypoperfusion underwent additional LTH-based EVT (stenting or shunt occlusion)

Period 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • All procedures were performed using classic orthotopic transplantations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 25, 2025

Study Start

February 1, 2016

Primary Completion

December 1, 2024

Study Completion

April 1, 2025

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share