Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients

Официальное название

The Clinical Efficacy of Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in Humoral Immune Markers from Baseline to 6 Months Postoperation [Срок оценки: Baseline (preoperative) and 6 months postoperation]
• Platelet Count at 6 Months Postoperation [Срок оценки: 6 months postoperation]
• White Blood Cell Count at 6 Months Postoperation [Срок оценки: 6 months postoperation]
• Hemoglobin Level at 6 Months Postoperation [Срок оценки: 6 months postoperation]
• Blood Flow Velocity of the Portal Vein at 6 Months Postoperation [Срок оценки: 6 months postoperation]
• Vascular Diameter of the Portal Vein at 6 Months Postoperation [Срок оценки: 6 months postoperation]
• Blood Flow Velocity of the Splenic Vein at 6 Months Postoperation [Срок оценки: 6 months postoperation]
• Vascular Diameter of the Splenic Vein at 6 Months Postoperation [Срок оценки: 6 months postoperation]
• Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 6 Months Postoperation [Срок оценки: 6 months postoperation]
• Incidence of Portal Venous System Thrombosis within 6 Months Postoperation [Срок оценки: 6 months postoperation]

Вторичные конечные точки (12)

• Comparison of Humoral Immune Marker Levels at 7 Days Postoperation [Срок оценки: 7 days postoperation]
• Comparison of Humoral Immune Marker Levels at 3 months Postoperation [Срок оценки: 3 months postoperation]
• Platelet Count at 3 Months Postoperation [Срок оценки: 3 months postoperation]
• Platelet Count at 12 Months Postoperation [Срок оценки: 12 months postoperation]
• Platelet Count at 1 Month Postoperation [Срок оценки: 1 month postoperation]
• Comparison of Humoral Immune Marker Levels at 1 Month Postoperation [Срок оценки: 1 month postoperation]
• Comparison of Humoral Immune Marker Levels at 12 Months Postoperation [Срок оценки: 12 Months postoperation]
• White Blood Cell Count at 1 Month Postoperation [Срок оценки: 1 month postoperation]
• White Blood Cell Count at 3 Months Postoperation [Срок оценки: 3 months postoperation]
• White Blood Cell Count at 12 Months Postoperation [Срок оценки: 12 months postoperation]
• Hemoglobin Level at 1 Month Postoperation [Срок оценки: 1 month postoperation]
• Hemoglobin Level at 3 Months Postoperation [Срок оценки: 3 months postoperation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Clinical Medical College of Yangzhou University — Yangzhou

Идентификаторы

NCT: NCT07205471 · YZUC-014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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