Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection

NCT07462091 | Recruiting DMC

• 1 other identifier: YZUC-015
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Cirrhosis; Hypersplenism; Hypertension, Portal

Keywords

Laparoscopy; Vagus nerve; Cirrhosis; Azygoportal disconnection; Splenectomy

Outcome Measures

Primary Outcomes (2)

• Incidence of Postoperative Diarrhea

  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

  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 Outcomes (5)

• Incidence of Postoperative Digestive System Complications (Composite)

  3 months

• Incidence of Esophagogastric Variceal Re-bleeding

  3 months

• Change in Body Weight

  3 months

• Change in Alanine Aminotransferase (ALT) Levels、Aspartate Aminotransferase (AST) Levels

  3 months

• Change in Serum Creatinine (Cr) Levels

  3 months

Study Arms (1)

Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection

EXPERIMENTAL

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

Interventions

Vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection PROCEDURE

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.

Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
• Splenomegaly with secondary hypersplenism
• Bleeding portal hypertension
• No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT
• Informed consent to participate in the study

You may not qualify if:

• Delayed gastric emptying
• Diarrhea
• Hepatocellular carcinoma or any other malignancy,
• Hypercoagulable state other than the liver disease related
• DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
• Child - Pugh C
• Recent peptic ulcer disease
• History of Hemorrhagic stroke
• Pregnancy.
• Uncontrolled Hypertension
• Human immunodeficiency virus (HIV) infection

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (2)

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

RECRUITING

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, 225001, China

COMPLETED

MeSH Terms

Conditions

Fibrosis; Hypersplenism; Hypertension, Portal

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Splenic Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Dou-Sheng Bai, MD

  Clinical Medical College, Yangzhou University

  STUDY CHAIR

• Guo-Qing Jiang, MD

  Clinical Medical College, Yangzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo-Qing Jiang, MD

CONTACT

+86-514-87373272; jgqing2003@hotmail.com

Dou-sheng Bai, MD

CONTACT

86-514-87373275; bdsno1@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 10, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)