Modified Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection

Not Applicable

Completed

• Conditions: Hypertension; Laparoscopy; Splenectomy; Cirrhosis
• Interventions: Procedure: Vagus nerve-preserving group

• Registration Number: NCT03396796
• Lead Sponsor: Yangzhou University

Brief Summary

This study aimed to evaluate whether vagus nerve-preserving laparoscopic 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 laparoscopic 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-preserving laparoscopic splenectomy and azygoportal disconnection) or control (conventional laparoscopic splenectomy and azygoportal disconnection) group. From postoperative day 3, all patients will receive 100 mg oral aspirin enteric-coated tablets (Bayer, Leverkusen, Germany) once daily for 1 year, 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, 9, and 12 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, months 1, 3, 6, 9, and 12 after operation. Then one year monitoring will be done in the both groups as per the primary or secondary outcome.

Study Timeline

• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-11
• Study Start: 2018-04-09
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-18
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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
• Age>75 yrs
• Human immunodeficiency virus (HIV) infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vagus nerve-preserving group	Vagus nerve-preserving group	Every patient of vagus nerve-preserving group will receive the modified vagus nerve-preserving laparoscopic azygoportal disconnection procedure.

Primary Outcome Measures

Name	Time	Method
Delayed gastric emptying	1 year	Proportions of patients who will suffer from delayed gastric emptying in both groups.

Secondary Outcome Measures

Name	Time	Method
Portal vein system thrombosis	1 year	Proportions of patients who will suffer from portal vein system thrombosis in both groups.
Overall survival	1 year	Overall survival in both groups.
Body weight	1 year	Proportions of patients who will show improvement in body weight both groups.
Hepatic decompensation	1 year	Proportions of patients who will suffer from hepatic decompensation defined as development of ascites, PSE, portal hypertensive bleeding, jaundice, spontaneous bacterial peritonitis, or systemic infection.
Postoperative complications of the digestive system	1 year	Proportions of patients who will suffer from postoperative complications of the digestive system in both groups.
Hepatocellular carcinoma	1 year	Proportions of patients who will suffer from hepatocellular carcinoma in both groups.

Trial Locations

Locations (1)

Clinical Medical College of Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China