Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients

NCT07205471 | Recruiting DMC

• 1 other identifier: YZUC-014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhoses, Liver; Splenectomy; Status; Partial

Keywords

Cirrhosis; Splenectomy; Laparoscopy; immune function; partial

Outcome Measures

Primary Outcomes (10)

• 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.

  Baseline (preoperative) and 6 months postoperation

• Platelet Count at 6 Months Postoperation

  Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.

  6 months postoperation

• White Blood Cell Count at 6 Months Postoperation

  White blood cell count (×10⁹/L) will be compared between groups.

  6 months postoperation

• Hemoglobin Level at 6 Months Postoperation

  Hemoglobin concentration (g/L) will be compared between groups.

  6 months postoperation

• Blood Flow Velocity of the Portal Vein at 6 Months Postoperation

  Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups.

  6 months postoperation

• Vascular Diameter of the Portal Vein at 6 Months Postoperation

  Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups.

  6 months postoperation

• Blood Flow Velocity of the Splenic Vein at 6 Months Postoperation

  Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.

  6 months postoperation

• Vascular Diameter of the Splenic Vein at 6 Months Postoperation

  Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups.

  6 months postoperation

• Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 6 Months Postoperation

  Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.

  6 months postoperation

• Incidence of Portal Venous System Thrombosis within 6 Months Postoperation

  The number of participants with newly developed thrombosis in the portal venous system, confirmed by imaging, will be recorded and compared.

  6 months postoperation

Secondary Outcomes (26)

• Comparison of Humoral Immune Marker Levels at 7 Days Postoperation

  7 days postoperation

• Comparison of Humoral Immune Marker Levels at 3 months Postoperation

  3 months postoperation

• Platelet Count at 3 Months Postoperation

  3 months postoperation

• Platelet Count at 12 Months Postoperation

  12 months postoperation

• Platelet Count at 1 Month Postoperation

  1 month postoperation

Study Arms (2)

laparoscopic splenectomy

NO INTERVENTION

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

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

Procedure: Laparoscopic Partial Splenectomy

Interventions

Laparoscopic Partial Splenectomy PROCEDURE

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

laparoscopic partial splenectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

RECRUITING

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guo-Qing Jiang

  Clinical Medical College, Yangzhou University

  STUDY CHAIR

Central Study Contacts

Guo-Qing Jiang

CONTACT

+8651487373382; jgqing2003@hotmail.com

Dou-Sheng Bai

CONTACT

+8651487373382; jgqing2003@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: October 3, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): September 24, 2028
• Study Completion (Estimated): September 24, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)