Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthern Jiangsu People's Hospital
About this trial
In this study,the researchers compared the changes in immune function-related indicators in patients with liver cirrhosis following laparoscopic partial splenectomy,to determine whether this surgical intervention can enhance postoperative immune function and thereby improve patient outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Hepatocellular carcinoma or any other malignancy,
Child-Pugh grade C
Recent peptic ulcer disease
History of Hemorrhagic stroke
Trial design
Design model
Parallel
Treatments tested in this trial
Laparoscopic Partial Splenectomy
Procedure/SurgeryThe laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: laparoscopic splenectomyNo intervention 0 interventions
Group B: laparoscopic partial splenectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Humoral Immune Markers from Baseline to 6 Months Postoperation
Serum levels of immunoglobulins (IgG, IgA, IgM), complement proteins (C3, C4), and B-cell markers (CD19, CD20) will be measured. The primary outcome is the change in these markers from preoperative baseline to 6 months after surgery.
Time frame
Baseline (preoperative) and 6 months postoperation2
Platelet Count at 6 Months Postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
Time frame
6 months postoperation3
White Blood Cell Count at 6 Months Postoperation
White blood cell count (×10⁹/L) will be compared between groups.
Time frame
6 months postoperation4
Hemoglobin Level at 6 Months Postoperation
Hemoglobin concentration (g/L) will be compared between groups.
Time frame
6 months postoperationSecondary outcomes
1
Comparison of Humoral Immune Marker Levels at 7 Days Postoperation
Serum levels of key humoral immune markers (including but not limited to IgG, IgA, IgM, C3, C4, CD19, CD20) will be compared between the laparoscopic partial splenectomy group and the total splenectomy group at 7 days after surgery.
Time frame
7 days postoperation2
Comparison of Humoral Immune Marker Levels at 3 months Postoperation
Serum levels of key humoral immune markers (IgG, IgA, IgM, C3, C4, CD19, CD20) will be compared between the two groups at this time point
Time frame
3 months postoperation3
Platelet Count at 3 Months Postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
Time frame
3 months postoperation4
Platelet Count at 12 Months Postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
Time frame
12 months postoperationSponsors and contacts
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Source ClinicalTrials.gov