Tokyo, March 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060819) titled 'A Single-Center Randomized Controlled Trial Evaluating the Efficacy of Simultaneous Splenectomy in Living-Donor Liver Transplantation' on March 4.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Kyushu University

Condition: Condition - Liver cirrhosis, liver failure Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The present study aims to evaluate the clinical significance of simultaneous splenectomy in living donor liver transplantation (LDLT) through a prospective randomized controlled trial (RCT). In this trial, patients undergoing simultaneous splenectomy will be compared with those who do not undergo splenectomy to determine whether the procedure contributes to improved liver graft function, reduced postoperative complications, and enhanced graft survival. Particular attention will be given to the incidence of Small-for-Size Graft Syndrome (SFSS), with the goal of establishing evidence to optimize the indications for splenectomy. The results of this study are expected to promote the standardization of splenectomy in LDLT and contribute to improved transplant outcomes and better patient prognosis. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - 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. Interventions/Control_2 - Non-splenectomy group (non-Spx group): During living-donor liver transplantation using a right lobe graft, splenectomy is not performed and the spleen is preserved.

Eligibility: Age-lower limit - 18 years-old 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 Key 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 Target Size - 80

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 07 Month 10 Day Date of IRB - 2025 Year 07 Month 10 Day Anticipated trial start date - 2025 Year 07 Month 11 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069593

Disclaimer: Curated by HT Syndication.