Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients (LPSH)

Northern Jiangsu People's Hospital

Status: Enrolling

Conditions: Partial; Splenectomy; Status; Cirrhoses, Liver

Treatments: Procedure: Laparoscopic Partial Splenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07205471

YZUC-014

Details and patient eligibility

About

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.

Full description

Patients meeting the study's inclusion criteria were enrolled, and their baseline demographic data were collected. Eligible patients were randomly assigned in a 1:1 ratio to two groups: the laparoscopic splenectomy group and the laparoscopic partial splenectomy group, using a computer-generated randomization sequence. Following comprehensive preoperative preparation, all surgeries were performed by the same surgical team. The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.

Postoperatively, all patients received standardized care from the same nursing team, followed by a uniform treatment protocol that included pharmacotherapy, additional therapeutic interventions, and follow-up assessments. Throughout the treatment period, monitoring was performed preoperatively and at 7 days, 1, 3, 6, and 12 months postoperatively. The parameters monitored included routine blood tests, liver function, coagulation profile, immune function, and hemodynamics of the portal vein, proper hepatic artery, and splenic vein.Additionally, indocyanine green (ICG) clearance tests were performed at 3, 6, and 12 months to assess liver function.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

laparoscopic splenectomy

No Intervention group

Description:

Patients in this arm undergo the standard laparoscopic splenectomy procedure, which serves as the active comparator. The entire spleen is removed after careful dissection and ligation of the splenic hilum.

laparoscopic partial splenectomy

Experimental group

Description:

The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.

Treatment:

Procedure: Laparoscopic Partial Splenectomy