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A Single-Center Randomized Controlled Trial Evaluating the Efficacy of Simultaneous Splenectomy in Living-Donor Liver Transplantation

Benefit of Optimal Outcome with Simultaneous Splenectomy in Living-Donor Liver Transplantation (BOOST Trial) - Benefit of Optimal Outcome with Simultaneous Splenectomy in Living-Donor Liver Transplantation (BOOST Trial)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060819
Enrollment
80
Registered
2026-03-04
Start date
2025-07-11
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Liver cirrhosis, liver failure

Interventions

Simultaneous splenectomy group (Spx group): During living-donor liver transplantation using a right lobe graft, splenectomy is performed simultaneously as part of the surgical procedure. Non-splenecto

Sponsors

Kyushu University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients meeting all of the following criteria will be eligible for inclusion: 1. Patients undergoing living-donor liver transplantation using a right lobe graft at the participating institution after study approval 2. Age >18 years 3. Graft-to-recipient weight ratio (GRWR) <0.8% based on preoperative evaluation 4. Patients who have provided written informed consent after receiving sufficient explanation of the study purpose and procedures

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will be excluded: 1. History of previous splenectomy 2. Marked anatomical variations of graft vasculature (portal vein, bile duct, hepatic artery, or hepatic vein) detected on preoperative imaging (plain or contrast-enhanced CT) and judged by the investigator to make the patient unsuitable for the study 3. Severe comorbidities (e.g., end-stage renal failure, severe cardiac disease, or active infection) that would increase the risk of simultaneous splenectomy 4. Severe perisplenic adhesions or inflammatory involvement identified by preoperative imaging or clinical findings that may increase the risk of splenectomy 5. Patients who decline participation after receiving adequate explanation of the study 6. Patients found intraoperatively to have a prior splenectomy, which will be treated as post-hoc ineligible cases

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is the incidence of Small-for-Size Graft Syndrome (SFSS) following living-donor liver transplantation. The diagnosis and grading of SFSS will be determined according to consensus criteria, including those proposed by the International Liver Transplantation Society (ILTS), based on postoperative clinical findings and laboratory parameters such as total bilirubin levels, INR, and ascites volume.

Secondary

MeasureTime frame
Key secondary outcomes include the following: portal venous pressure at abdominal closure, portal venous flow after reperfusion, total intraoperative blood loss, operative time, blood loss during splenectomy, cold ischemia time, warm ischemia time, anhepatic phase duration, incidence of postoperative complications (postoperative bleeding, pancreatic fistula, portal vein thrombosis, sepsis, and acute rejection), length of postoperative hospital stay, 30-day postoperative mortality, 1-year survival, and postoperative liver function parameters (AST, ALT, ALP, GGTP, LDH, PT [% and INR], total bilirubin, direct bilirubin, and platelet count).

Countries

Japan

Contacts

Public ContactTakeo Toshima

Graduate School of Medical Sciences, Kyushu University Department of Surgery and Science

toshima.takeo.962@m.kyushu-u.ac.jp+81-92-642-5466

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026