Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection (VNLSD)

March 26, 2026 updated by: Guo-Qing Jiang, Northern Jiangsu People's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Recruiting
        • Clinical Medical College of Yangzhou University
        • Contact:
        • Contact:
      • Yangzhou, Jiangsu, China, 225001
        • Completed
        • Clinical Medical College, Yangzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection
Procedure/Surgery: vagus nerve-guided group 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.
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) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative Diarrhea
Time Frame: 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)
3 months
Incidence of Delayed Gastric Emptying
Time Frame: 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]
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Jiangsu People's Hospital

Investigators

  • Study Chair: Dou-Sheng Bai, MD, Clinical Medical College, Yangzhou University
  • Principal Investigator: Guo-Qing Jiang, MD, Clinical Medical College, Yangzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

March 1, 2026

First Submitted That Met QC Criteria

March 7, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YZUC-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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