Vagus nerve–guided laparoscopic spleen removal with azygoportal disconnection
Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection
This procedure tests whether a vagus nerve–guided laparoscopic spleen removal plus azygoportal disconnection helps people with cirrhosis, portal hypertension, and hypersplenism who have had gastroesophageal variceal bleeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northern Jiangsu People's Hospital Academic / other |
| Locations | 2 sites (Yangzhou, Jiangsu and 1 other locations) |
| Trial ID | NCT07462091 on ClinicalTrials.gov |
What this trial studies
Adults with cirrhosis and secondary hypersplenism who have had gastroesophageal variceal bleeding are enrolled after screening and baseline measurements. All participants undergo a vagus nerve–guided laparoscopic splenectomy with azygoportal disconnection and then receive a standardized postoperative anticoagulation regimen (apixaban for 6 months, short-course low‑molecular‑weight heparin, and dipyridamole for 3 months). Digestive symptoms, liver and renal function, weight, and complications are recorded at postoperative day 7 and month 3, and gastroscopy for delayed gastric emptying is performed at 3 months. Primary and secondary outcomes are monitored over the 3‑month postoperative period.
Who should consider this trial
Good fit: Ideal candidates are patients with cirrhosis (not Child‑Pugh C) who have splenomegaly with secondary hypersplenism and bleeding from portal hypertension, with no portal vein thrombosis and who can take the required postoperative medications.
Not a fit: Patients with delayed gastric emptying or diarrhea at baseline, hepatocellular carcinoma or other malignancy, active hypercoagulable states, portal vein thrombosis, Child‑Pugh C cirrhosis, pregnancy, uncontrolled hypertension, HIV, or current use of anticoagulant/antiplatelet drugs are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the procedure could reduce variceal bleeding and correct hypersplenism while minimizing postoperative digestive complications and improving quality of life.
How similar studies have performed: Laparoscopic splenectomy and azygoportal disconnection have been used in cirrhotic portal hypertension with some positive reports, but the vagus nerve–guided variant has relatively limited published outcome data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Yangzhou, Jiangsu and 1 other locations
- Clinical Medical College of Yangzhou University — Yangzhou, Jiangsu, China (Recruiting)
- Clinical Medical College, Yangzhou University — Yangzhou, Jiangsu, China (Completed)
Study contacts
- Principal investigator: Guo-Qing Jiang, MD — Clinical Medical College, Yangzhou University
- Study coordinator: Guo-Qing Jiang, MD
- Email: jgqing2003@hotmail.com
- Phone: +86-514-87373272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.