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Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection

Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

After successful screening, cases of liver cirrhosis irrespective of etiology with gastroesophageal variceal bleeding and secondary hypersplenism owing to cirrhotic portal hypertension 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.

Eligibility

Inclusion Criteria:

  1. A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
  2. Splenomegaly with secondary hypersplenism
  3. Bleeding portal hypertension
  4. No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT
  5. Informed consent to participate in the study

Exclusion Criteria:

  1. Delayed gastric emptying
  2. Diarrhea
  3. Hepatocellular carcinoma or any other malignancy,
  4. Hypercoagulable state other than the liver disease related
  5. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
  6. Child - Pugh C
  7. Recent peptic ulcer disease
  8. History of Hemorrhagic stroke
  9. Pregnancy.
  10. Uncontrolled Hypertension
  11. Human immunodeficiency virus (HIV) infection

Study details
    Cirrhosis
    Hypersplenism
    Hypertension
    Portal

NCT07462091

Northern Jiangsu People's Hospital

13 May 2026

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