Cirrhosis, Hypersplenism, Hypertension, Portal
Conditions
Keywords
Laparoscopy, Vagus nerve, Cirrhosis, Azygoportal disconnection, Splenectomy
Brief summary
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
PROCEDUREVagus 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) 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.
Sponsors
Northern Jiangsu People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Diarrhea | 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 | 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) \[Time Frame: 3 months\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Digestive System Complications (Composite) | 3 months | Percentage of participants experiencing at least one episode of diarrhea, epigastric fullness, bloating, nausea, or vomiting within 3 months post-surgery, as documented in medical records. (Measurement Tool: Electronic Medical Record System and Clinical Adverse Event Case Report Form; Unit of Measure: Percentage of participants with the event) |
| Incidence of Esophagogastric Variceal Re-bleeding | 3 months | Percentage of participants with confirmed re-bleeding events within 3 months post-surgery, as determined by an endpoint adjudication committee based on endoscopic evidence or clinical signs (e.g., hematemesis, melena). (Measurement Tool: Endoscopy Reports and Clinical Laboratory Data; Unit of Measure: Percentage of participants with the event) |
| Change in Body Weight | 3 months | Absolute change in body weight (kg) from baseline to 3 months post-surgery, measured using a calibrated electronic scale with participants in a fasting state, after voiding, and wearing light indoor clothing. (Measurement Tool: Calibrated Electronic Scale; Unit of Measure: kg) |
| Change in Alanine Aminotransferase (ALT) Levels、Aspartate Aminotransferase (AST) Levels | 3 months | Change in AST activity (U/L) and AST activity (U/L) in fasting venous blood from baseline to 3 months post-surgery, measured using an automated chemistry analyzer. (Measurement Tool: Automated Chemistry Analyzer; Unit of Measure: U/L) |
| Change in Serum Creatinine (Cr) Levels | 3 months | Change in Cr concentration (μmol/L) in fasting venous blood from baseline to 3 months post-surgery, measured using an automated chemistry analyzer. (Measurement Tool: Automated Chemistry Analyzer; Unit of Measure: μmol/L) |
Countries
China
Contacts
CONTACTGuo-Qing Jiang, MD
CONTACTDou-sheng Bai, MD
STUDY_CHAIRDou-Sheng Bai, MD
Clinical Medical College, Yangzhou University
PRINCIPAL_INVESTIGATORGuo-Qing Jiang, MD
Clinical Medical College, Yangzhou University
Outcome results
None listed