CirrhosisVNLSDNCT07462091
Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection
A study testing Vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection in people with Cirrhosis and Hypersplenism, run by Northern Jiangsu People's Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Hypersplenism, Hypertension, Portal
- What is being tested?
- Vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesChina
- Study dates
- 25 Mar 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Recent peptic ulcer disease
- History of Hemorrhagic stroke
- Pregnancy.
- Uncontrolled Hypertension
- Human immunodeficiency virus (HIV) infection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Recruiting
Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, 225001
Guo-Qing Jiang, MS, 86-514-87373372, jgqing2003@hotmail.com
Dou-Sheng Bai, MD, 86-514-87373375, bdsno1@hotmail.com
- Completed
Clinical Medical College, Yangzhou University
Yangzhou, Jiangsu, 225001
About this study
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.
Read the 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.
- Conditions
- Cirrhosis, Hypersplenism, Hypertension, Portal
- Being tested
- Vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection
- Keywords
- Laparoscopy, Vagus nerve, Cirrhosis, Azygoportal disconnection, Splenectomy
- Medical subject headings
- Fibrosis, Hypersplenism, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve-guided laparoscopic splenectomy and azygoportal disconnectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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]
Measured: 3 months
Secondary outcomes (5)
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)
Measured: 3 months
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)
Measured: 3 months
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)
Measured: 3 months
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)
Measured: 3 months
Change in Serum Creatinine (Cr) Levels
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start25 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-Qing Jiang, Northern Jiangsu People's Hospital
- Investigators
- Dou-Sheng Bai, MD, Study chair, Clinical Medical College, Yangzhou UniversityGuo-Qing Jiang, MD, Principal investigator, Clinical Medical College, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462091
- Sponsor's protocol ID
- YZUC-015
- Acronym
- VNLSD
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection
- ClinicalTrials.gov ID
- NCT07462091
- Acronym / sponsor ID
- VNLSD / YZUC-015
- Conditions
- Cirrhosis, Hypersplenism, Hypertension, Portal
- Keywords
- Laparoscopy, Vagus nerve, Cirrhosis, Azygoportal disconnection, Splenectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection | Experimental | Procedure: Vagus nerve-guided laparoscopic splenectomy and azygoportal disconnectionProcedure/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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus nerve-guided laparoscopic splenectomy and azygoportal disconnectionThe 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 or surgery | Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection |
Primary outcome
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)
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]
5 secondary outcomes
Incidence of Postoperative Digestive System Complications (Composite)
Time frame: 3 months
Incidence of Esophagogastric Variceal Re-bleeding
Time frame: 3 months
Change in Body Weight
Time frame: 3 months
Change in Alanine Aminotransferase (ALT) Levels、Aspartate Aminotransferase (AST) Levels
Time frame: 3 months
Change in Serum Creatinine (Cr) Levels
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dou-Sheng Bai, MD study chair
Clinical Medical College, Yangzhou University
Guo-Qing Jiang, MD principal investigator
Clinical Medical College, Yangzhou University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection in people with Cirrhosis and Hypersplenism, run by Northern Jiangsu People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guo-Qing Jiang, MD (+86-514-87373272, jgqing2003@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Diarrhea (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.