Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07462091

Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection for Cirrhosis with Portal Hypertension and Hypersplenism

Led by Northern Jiangsu People's Hospital · Updated on 2026-04-01

15

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a surgical procedure called vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection in patients with liver cirrhosis, gastroesophageal variceal bleeding, and secondary hypersplenism due to cirrhotic portal hypertension. The study aims to understand how this procedure affects postoperative digestive complications and the quality of life for these patients. All enrolled patients will undergo the vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection procedure, which involves careful dissection to preserve specific nerve branches while removing the spleen and disconnecting certain blood vessels. After surgery, patients will receive specific medications including oral Apixaban twice daily for 6 months, subcutaneous low-molecular-weight heparin for 5 days, and oral dipyridamole three times daily for 3 months. At 3 months post-operation, an electron gastroscopy exam will check for delayed gastric emptying. Participants will be closely monitored for digestive complications such as diarrhea, bloating, nausea, and vomiting at 7 days and 3 months after surgery. Liver and kidney function tests, as well as body weight, will also be tracked. The main outcomes measured include the incidence of postoperative diarrhea and delayed gastric emptying at 3 months. Additional outcomes include digestive complications, variceal re-bleeding, changes in body weight, and liver and kidney function markers. The total follow-up period is at least 3 months after the operation.

CONDITIONS

Brief Title

Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A clinical, radiological, or histologic diagnosis of cirrhosis of any cause
  • Presence of splenomegaly with secondary hypersplenism
  • Evidence of bleeding portal hypertension
  • No portal vein thrombosis as confirmed by ultrasound and angio-CT
  • Ability to provide informed consent to participate
Not Eligible

You will not qualify if you...

  • Presence of delayed gastric emptying
  • Experiencing diarrhea
  • Diagnosis of hepatocellular carcinoma or any other cancer
  • Hypercoagulable state unrelated to liver disease
  • Current use of oral contraceptives, anticoagulants, or anti-platelet drugs
  • Child-Pugh classification C
  • Recent peptic ulcer disease
  • History of hemorrhagic stroke
  • Pregnancy
  • Uncontrolled hypertension
  • Infection with human immunodeficiency virus (HIV)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Surgery and Immediate Post-operative Care

Duration - 6 months

Participants undergo vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection. Starting on postoperative day 3, participants take oral Apixaban twice daily for 6 months, receive subcutaneous low-molecular-weight heparin for 5 days, and take oral dipyridamole thrice daily for 3 months. Postoperative complications and laboratory parameters are monitored.

visits on postoperative day 7 and month 3; electron gastroscopy at month 3

Post-operative Follow-up

Duration - 3 months

Participants are monitored for postoperative complications, body weight changes, and liver and renal function as per primary and secondary outcomes.

3-month monitoring visits

Trial Site Locations

Total: 2 locations

1

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, China, 225001

Actively Recruiting

2

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, China, 225001

Completed

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Research Team

G

Guo-Qing Jiang, MD

D

Dou-sheng Bai, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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