Vagus Nerve-guided Robotic-assisted Splenectomy and Azygoportal Disconnection

Hypertension Clinical Trial

— VNRSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05300516
• Other study ID #: YZUC-008
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: December 2023
• Source: Northern Jiangsu People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hypertension
• Splenectomy

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Clinical Medical College, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Northern Jiangsu People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diarrhea	Proportions of patients who will suffer from diarrhea in both groups.	3 month
Primary	Delayed gastric emptying	Proportions of patients who will suffer from delayed gastric emptying in both groups.	3 month
Secondary	Postoperative complications of the digestive system	Proportions of patients who will suffer from postoperative complications of the digestive system in both groups.	3 month
Secondary	Esophagogastric variceal re-bleeding	Proportions of patients who will suffer from esophagogastric variceal re-bleeding in both groups.	3 month