Modified Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection

Hypertension Clinical Trial

— ESVLSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396796
• Other study ID #: YZUC-003
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hypertension
• Laparoscopy
• Splenectomy

Intervention

Procedure:
• Vagus nerve-preserving group
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed gastric emptying	Proportions of patients who will suffer from delayed gastric emptying in both groups.	1 year
Secondary	Postoperative complications of the digestive system	Proportions of patients who will suffer from postoperative complications of the digestive system in both groups.	1 year
Secondary	Body weight	Proportions of patients who will show improvement in body weight both groups.	1 year
Secondary	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
Secondary	Portal vein system thrombosis	Proportions of patients who will suffer from portal vein system thrombosis in both groups.	1 year
Secondary	Hepatocellular carcinoma	Proportions of patients who will suffer from hepatocellular carcinoma in both groups.	1 year
Secondary	Overall survival	Overall survival in both groups.	1 year