Vagus nerve–guided laparoscopic spleen removal with azygoportal disconnection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.