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Evaluation of the Safety and Efficacy of Pure Laparoscopic Full-size Liver Transplantation in Adult Patients with End-Stage Liver Disease: A Single-Center, Prospective, Single-Arm, IDEAL 2a Phase Clinical Study

Evaluation of the Safety and Efficacy of Pure Laparoscopic Full-size Liver Transplantation in Adult Patients with End-Stage Liver Disease: A Single-Center, Prospective, Single-Arm, IDEAL 2a Phase Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101767
Enrollment
Unknown
Registered
2025-04-29
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Liver Disease

Interventions

Pure Laparoscopic full-size Liver Transplantation Group.:Pure laparoscopic full-size liver transplantation

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Donor Inclusion Criteria (meet the following 2 criteria): 1. Brain-dead organ donation (DBD) donors; 2. >=16 years; Receptor inclusion criteria (meet the following 5 criteria): 1. Age>=18 years and <=75 years; 2. Patients with end-stage liver disease who are on the liver transplant waiting list; 3. Agree to accept donor liver from brain-dead patients (DBD); 4. Large abdominal space, small size of diseased liver, and spontaneous portosystemic shunt; 5. The person or guardian agrees to participate in the clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Donor Exclusion Criteria (meet any of the following): 1. Donor liver for split liver transplantation or reduced-volume liver transplantation; 2. HIV-positive patients donor liver; 3. Presence of moderate to severe hepatic trauma, active hepatic bleeding, liver abscess or even after reconstruction that affects effective perfusion Note the anatomical variation of the portal vein or hepatic artery of the donor liver. 4. Huge donor liver 5.4 Recipient exclusion criteria (meet any of the following): 1. Multi-organ transplantation or combined organ transplantation; 2. ABO incompatible liver transplantation 3. Patients with fulminant liver failure 4. Pregnant women; 5. Have a history of organ transplantation or bone marrow transplantation; 6. Ventilator-assisted ventilation is required before enrollment; 7. Intravenous vasoconstrictor drugs should be administered to maintain hemodynamic stability before enrollment; 8. Continuous renal replacement therapy is required before enrollment; 9. Subjects who are in other interventional clinical trials and have not met the study endpoints; 10. Other conditions that the investigator considers inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
lGSAE;

Secondary

MeasureTime frame
Incidence of Incision Complications.;Incidence of Post-reperfusion Syndrome;Patient satisfaction with the incision, quality of life;Incidence of Surgical Complications;Graft survival, recipient survival.;Incidence of Early Allograft Dysfunction;

Countries

China

Contacts

Public ContactWu Wenrui

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

wuwr@mail.sysu.edu.cn+86 20 34070840

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026