Laparoscopic Splenectomy and Azygoportal Disconnection With Intraoperative Endoscopic Variceal Ligation

Hypertension Clinical Trial

— SVEL  

Official title:

Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection With Versus Without Intraoperative Endoscopic Variceal Ligation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04244487
• Other study ID #: YZUC-004
• Status: Completed
• Phase: N/A
• Start date: January 3, 2020
• Est. completion date: December 31, 2021

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 synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (SVEL) is effective and safe, and to determine whether SVEL can effectively decrease the incidence of postoperative esophageal variceal re-bleeding.

Description:

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have prior esophageal/gastroesophageal variceal bleeding will be enrolled. The baseline parameter will be recorded and the patient will be randomized into either interventional (synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (SVEL)) or control (single vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection without intraoperative endoscopic variceal ligation (SVEL)) 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, 6, and 12 after operation, endoscopic intervention will be done for all patients. Endoscopic variceal ligation was made if the diameter of the esophageal varices was >5 mm. Postoperative complications of esophageal variceal re-bleeding and death due to re-bleeding will be recorded during the postoperative first year monitoring in the both groups as per the primary or secondary outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• A clinical, radiological or histologic diagnosis of cirrhosis of any etiology

• Splenomegaly with secondary hypersplenism

• esophageal/gastroesophageal variceal bleeding

• No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT

• Informed consent to participate in the study

Exclusion Criteria:

• 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:
• laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation
The modified procedure was implemented in the following order: (1) find the left crural diaphragm; (2) via the surface of the left crural diaphragm, divide the left lateral surface of the distal esophagus; (3) divide the posterior surface of the distal esophagus; (4) divide the anterior surface of the distal esophagus; (5) divide the lesser omental sac via the bottom right crural diaphragm; (6) transect en bloc the left gastric artery and vein and posterior gastric veins using a linear laparoscopic vascular stapler; (7) find the right crural diaphragm by dividing a small portion of the hepatogastric ligament at the left lateral esophagogastric junction; and (8) via the surface of the right crural diaphragm, divide the right lateral surface of the distal esophagus. After the procedure of laparoscopic azygoportal disconnection, intraoperative endoscopic variceal ligation was made if the diameter of the esophageal varices was >5 mm.

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	Esophageal variceal re-bleeding	Proportions of patients who will suffer from esophageal variceal re-bleeding	1 year
Secondary	Death due to re-bleeding	Proportions of patients who will suffer from death due to re-bleeding	1 year
Secondary	Overall survival	Overall survival in both groups	1 year