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NCT Number: NCT05300516

Vagus Nerve-guided Robotic-assisted Splenectomy and Azygoportal Disconnection

This study aimed to evaluate whether vagus nerve-guided robotic-assisted splenectomy and azygoportal disconnection is effective and safe, and to determine whether a reduction in the incidence of postoperative complications of the digestive system improves postoperative quality of life compared with conventional robotic-assisted splenectomy and azygoportal disconnection.

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Key information

Conditions

Cirrhosis Cardiovascular Diseases Digestive System Diseases Fibrosis Gastrointestinal Diseases Gastroparesis Hypertension Neurologic Manifestations Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Robotic-assisted Signs and Symptoms Splenectomy Stomach Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, 225001, China

About this study

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline parameter will be recorded and the patient will be randomized into either interventional (vagus nerve-guided robotic-assisted splenectomy and azygoportal disconnection) or control (conventional robotic-assisted splenectomy and azygoportal disconnection) group. 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 months 3 after operation, electron gastroscopy examination for delayed gastric emptying will be done 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 the seventh day and months 3 after operation. Then 3 months monitoring will be done in the both groups as per the primary or secondary outcome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

vagus nerve-guided group

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.

Primary outcomes

  1. Diarrhea

    Time frame: 3 month

    Proportions of patients who will suffer from diarrhea in both groups.

  2. Delayed gastric emptying

    Time frame: 3 month

    Proportions of patients who will suffer from delayed gastric emptying in both groups.

Secondary outcomes

  1. Postoperative complications of the digestive system

    Time frame: 3 month

    Proportions of patients who will suffer from postoperative complications of the digestive system in both groups.

  2. Esophagogastric variceal re-bleeding

    Time frame: 3 month

    Proportions of patients who will suffer from esophagogastric variceal re-bleeding in both groups.

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

Vagus Nerve-guided Versus Conventional Robotic-assisted Splenectomy and Azygoportal Disconnection

Acronym: VNRSD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2022
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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