Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Diarrhea
研究概览
简要总结
This study aimed to evaluate the effectiveness and safety of vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection, and to assess its impact on postoperative digestive complications and quality of life.
详细描述
After successful screening, cases of liver cirrhosis irrespective of etiology who have non-tumor portal vein thrombosis will be enrolled. Baseline parameters will be recorded, and all patients will receive the interventional procedure (vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection). From postoperative day 3, all patients will receive 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months, low-molecular-weight heparin (CS Bio, Hebei, China) subcutaneously (4,100 IU/day) for 5 days, and 25 mg of oral dipyridamole (Henan Furen, Henan, China) thrice daily for 3 months. At month 3 after operation, electron gastroscopy examination for delayed gastric emptying will be performed for all patients. Postoperative complications of the digestive system (including diarrhea, epigastric fullness, bloating, nausea, and vomiting), liver and renal function, and body weight will be recorded at postoperative day 7 and month 3. Then, 3-month monitoring will be conducted as per the primary and secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
- •Splenomegaly with secondary hypersplenism
- •Bleeding portal hypertension
- •No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT
- •Informed consent to participate in the study
排除标准
- •Delayed gastric emptying
- •Hepatocellular carcinoma or any other malignancy,
- •Hypercoagulable state other than the liver disease related
- •DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
- •Child - Pugh C
- •Recent peptic ulcer disease
- •History of Hemorrhagic stroke
- •Uncontrolled Hypertension
- •Human immunodeficiency virus (HIV) infection
研究组 & 干预措施
Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection
Procedure/Surgery: vagus nerve-guided group The vagus nerve-guided procedure was performed in the following order: (1) find the left crural diaphragm; (2) via the surface of the left crural diaphragm, blunt dissect the left lateral surface of the distal esophagus using Bipolar Forceps, and find posterior vagal trunk; (3) along posterior vagal trunk towards left lateral esoph-agogastric junction, find and protect gastric and celiac branches; (4) enter the lesser omental sac from the right crural diaphragm using Bipolar Forceps; (5) transect the left gastric artery and vein together using a linear vascular stapler; (6) blunt dissect the anterior surface of the distal esophagus using Bipolar Forceps, and find anterior vagal trunk; (7) along anterior vagal trunk towards right lateral esoph-agogastric junction, find and protect gastric and hepatic branches; and (8) blunt dissect the right lateral surface of the distal esophagus. The hepatogastric ligament was conserved.
干预措施: Vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection (Procedure)
结局指标
主要结局
Incidence of Postoperative Diarrhea
时间窗: 3 months
Percentage of participants experiencing diarrhea within 3 months post-surgery, as documented in medical records or reported by participants. (Measurement Tool: Electronic Medical Record System and Clinical Adverse Event Case Report Form; Unit of Measure: Percentage of participants with the event)
Incidence of Delayed Gastric Emptying
时间窗: 3 months
Percentage of participants diagnosed with delayed gastric emptying within 3 months post-surgery, based on clinical symptoms and/or gastric emptying scintigraphy (if clinically indicated). (Measurement Tool: Clinical Assessment and Gastric Emptying Scintigraphy Report; Unit of Measure: Percentage of participants with the event) \[Time Frame: 3 months\]
次要结局
- Incidence of Postoperative Digestive System Complications (Composite)(3 months)
- Incidence of Esophagogastric Variceal Re-bleeding(3 months)
- Change in Body Weight(3 months)
- Change in Alanine Aminotransferase (ALT) Levels、Aspartate Aminotransferase (AST) Levels(3 months)
- Change in Serum Creatinine (Cr) Levels(3 months)
研究者
Guo-Qing Jiang
Clinical Professor
Northern Jiangsu People's Hospital