Modified Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Modified Vagus Nerve-preserving Versus Conventional Laparoscopic Splenectomy and Azygoportal Disconnection

Conditions
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Cirrhosis, Hypertension, Splenectomy, Laparoscopy

Intervention / Treatment
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* Procedure: Vagus nerve-preserving group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vagus nerve-preserving group<br>Every patient of vagus nerve-preserving group will receive the modified vagus nerve-preserving laparoscopic azygoportal disconnection procedure. | Procedure: Vagus nerve-preserving group<br>* The modified vagus nerve-preserving procedure was performed in the following order: (1) left gastroepiploic vein along greater curvature; (2) the posterior surface of stomach, including the posterior gastric veins; (3) the left lateral surface of the distal esophagus; (4) the left inferior phrenic veins; (5) the posterior surface of the distal esophagus;(6) the anterior surface of the distal esophagus; and (7) the right lateral surface of the distal esophagus. The hepatogastric ligament was conserved. the adherent junction between visceral peritoneum and the right crural diaphragm, and divided it into the lesser omental sac. The left gastric artery and vein and the posterior gastric veins were transected en bloc using a linear laparoscopic vascular stapler.<br>|
| No Intervention: Conventional group<br>Every patient of conventional group will receive the conventional laparoscopic azygoportal disconnection procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed gastric emptying | Proportions of patients who will suffer from delayed gastric emptying in both groups. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications of the digestive system | Proportions of patients who will suffer from postoperative complications of the digestive system in both groups. | 1 year | 
| Body weight | Proportions of patients who will show improvement in body weight both groups. | 1 year | 
| Hepatic decompensation | 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. | 1 year | 
| Portal vein system thrombosis | Proportions of patients who will suffer from portal vein system thrombosis in both groups. | 1 year | 
| Hepatocellular carcinoma | Proportions of patients who will suffer from hepatocellular carcinoma in both groups. | 1 year | 
| Overall survival | Overall survival in both groups. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vagus nerve, Delayed gastric emptying, Cirrhosis, Hypertension, laparoscopy