Laparoscopic partial removal of the spleen for hypersplenism in cirrhosis.
The Clinical Efficacy of Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients
This test tries whether removing part of the spleen by laparoscopy improves immune function and recovery in people with cirrhosis and hypersplenism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northern Jiangsu People's Hospital Academic / other |
| Locations | 1 site (Yangzhou, Jiangsu) |
| Trial ID | NCT07205471 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Prior surgical series and observational reports suggest partial splenectomy can better preserve immune function than total splenectomy, but randomized data are limited.
Eligibility criteria
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 this trial is running
Yangzhou, Jiangsu
- Clinical Medical College of Yangzhou University — Yangzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Guo-Qing Jiang
- Email: jgqing2003@hotmail.com
- Phone: +8651487373382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.