Laparoscopic partial removal of the spleen for hypersplenism in cirrhosis.
Official title: The Clinical Efficacy of Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients
Run by Northern Jiangsu People's Hospital · NCT07205471 · Data updated 2026-11-12
This test tries whether removing part of the spleen by laparoscopy improves immune function and recovery in people with cirrhosis and hypersplenism.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Northern Jiangsu People's Hospital Academic / other |
| Locations | 1 site (Yangzhou, Jiangsu) |
| Status | Recruiting |
| Started | September 24, 2025 |
| Main results expected | September 24, 2028 |
| Study ends | September 24, 2028 |
| Registry record updated | October 3, 2025 |
| Trial ID | NCT07205471 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with cirrhosis of any cause who have splenomegaly with secondary hypersplenism and gastroesophageal variceal bleeding, who meet surgical fitness criteria and give informed consent are ideal candidates.
✕Probably not a fit
Patients with Child-Pugh grade C liver disease, active malignancy, HIV infection, recent peptic ulcer or hemorrhagic stroke, uncontrolled hypertension, or pregnancy are excluded and unlikely to benefit from this procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Eligible patients with cirrhosis and hypersplenism were enrolled and randomly assigned 1:1 to either laparoscopic total splenectomy or laparoscopic partial splenectomy, with all operations performed by the same surgical team. The partial splenectomy technique preserved the short gastric vessels and splenic suspensory ligament and followed the intraoperative demarcation line. Postoperative care and medications were standardized and patients were followed at 7 days, and 1, 3, 6, and 12 months with routine blood tests, liver function, coagulation, immune markers, and vascular hemodynamics of the portal vein, proper hepatic artery, and splenic vein. Indocyanine green clearance tests were performed at 3, 6, and 12 months to track liver function over time.
Why it matters
Potential benefit: If successful, partial splenectomy could preserve more splenic immune function and lead to fewer infections and better blood- and liver-related outcomes compared with total splenectomy.
How similar studies have gone: Prior surgical series and observational reports suggest partial splenectomy can better preserve immune function than total splenectomy, but randomized data are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * A clinical, radiological or histologic diagnosis of cirrhosis of any etiology * Splenomegaly with secondary hypersplenism * gastroesophageal variceal bleeding * Informed consent to participate in the study Exclusion Criteria: * Hepatocellular carcinoma or any other malignancy, * Child-Pugh grade C * Recent peptic ulcer disease * History of Hemorrhagic stroke * Pregnancy. * Uncontrolled Hypertension * Human immunodeficiency virus (HIV) infection
Where it's running
-
Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Guo-Qing Jiang
- Email: jgqing2003@hotmail.com
- Phone: +8651487373382
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Education to prevent infections after spleen removal
See if a targeted educational program for adults who had their spleen removed improves vaccination uptake, awareness of infection risk, and continuity of care.
-
Italian questionnaire to measure knowledge and vaccination attitudes in people without a spleen
This project will test a new Italian questionnaire to measure how much people without a spleen know about infection prevention and vaccination.
-
Vaccination for patients without a spleen
This study is testing if the meningococcal B vaccine is safe and effective for people who don’t have a spleen compared to healthy individuals.
-
Laparoscopic surgery to improve immune function in cirrhosis patients
This study is testing if a specific type of surgery can help boost the immune system in people with liver cirrhosis who have an enlarged spleen.
-
Surgery to improve liver function in cirrhosis patients
This study tests whether a specific surgery can help improve liver function in patients with cirrhosis who have an enlarged spleen.
-
Laparoscopic splenectomy's effect on liver function in cirrhosis patients
This study tests if a minimally invasive surgery to remove the spleen can improve liver function in patients with cirrhosis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.