Clinical trial NCT05300516: Vagus Nerve-guided Robotic-assisted Splenectomy and Azygoportal Disconnection
Official title: Vagus Nerve-guided Versus Conventional Robotic-assisted Splenectomy and Azygoportal Disconnection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Hypertension
Splenectomy
Robotic-assisted
Keywords: Vagus nerve
Delayed gastric emptying
Cirrhosis
Hypertension
Robotic-assisted
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diarrhea
timeFrame: 3 month
measure: Delayed gastric emptying
timeFrame: 3 month
Secondary outcomes:
measure: Postoperative complications of the digestive system
timeFrame: 3 month
measure: Esophagogastric variceal re-bleeding
timeFrame: 3 month
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Clinical Medical College, Yangzhou University
state: Jiangsu
Study officials:
affiliation: Clinical Medical College, Yangzhou University
name: Dou-Sheng Bai, MD
role: STUDY_CHAIR
affiliation: Clinical Medical College, Yangzhou University
name: Guo-Qing Jiang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Medical College, Yangzhou University
name: Ping Chen, MD
role: STUDY_DIRECTOR
References: