Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthern Jiangsu People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Delayed gastric emptying
Diarrhea
Hepatocellular carcinoma or any other malignancy,
Hypercoagulable state other than the liver disease related
Trial design
Design model
Single group
Treatments tested in this trial
Vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection
Procedure/SurgeryThe 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal DisconnectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
3 months2
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) \[Time Frame: 3 months\]
Time frame
3 monthsSecondary outcomes
1
Incidence of Postoperative Digestive System Complications (Composite)
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)
Time frame
3 months2
Incidence of Esophagogastric Variceal Re-bleeding
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)
Time frame
3 months3
Change in Body Weight
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)
Time frame
3 months4
Change in Alanine Aminotransferase (ALT) Levels、Aspartate Aminotransferase (AST) Levels
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)
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov