Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection

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.

Detailed 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.

Interventions

• Procedure Vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection
  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) transec

Primary outcome measures

• Incidence of Postoperative Diarrhea [Time frame: 3 months]
• Incidence of Delayed Gastric Emptying [Time frame: 3 months]

Secondary outcome measures (5)

• Incidence of Postoperative Digestive System Complications (Composite) [Time frame: 3 months]
• Incidence of Esophagogastric Variceal Re-bleeding [Time frame: 3 months]
• Change in Body Weight [Time frame: 3 months]
• Change in Alanine Aminotransferase (ALT) Levels、Aspartate Aminotransferase (AST) Levels [Time frame: 3 months]
• Change in Serum Creatinine (Cr) Levels [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• Delayed gastric emptying
• Diarrhea
• 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
• Pregnancy.
• Uncontrolled Hypertension
• Human immunodeficiency virus (HIV) infection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

China · 2 centers

• Clinical Medical College of Yangzhou University — Yangzhou
• Clinical Medical College, Yangzhou University — Yangzhou

Identifiers

NCT: NCT07462091 · YZUC-015

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗