Laparoscopic Splenectomy and Azygoportal Disconnection With Intraoperative Endoscopic Variceal Ligation

Not Applicable

Completed

• Conditions: Splenectomy; Cirrhosis; Hypertension; Laparoscopy
• Interventions: Procedure: laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation

• Registration Number: NCT04244487
• Lead Sponsor: Northern Jiangsu People's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-03
• Study First Submitted: 2020-01-18
• Study First Submitted QC: 2020-01-26
• Study First Posted: 2020-01-28
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intraoperative endoscopic variceal ligation group	laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation	intraoperative endoscopic variceal ligation group Every patient of vagus nerve-preserving group will receive the synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation procedure

Primary Outcome Measures

Name	Time	Method
Esophageal variceal re-bleeding	1 year	Proportions of patients who will suffer from esophageal variceal re-bleeding

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year	Overall survival in both groups
Death due to re-bleeding	1 year	Proportions of patients who will suffer from death due to re-bleeding

Trial Locations

Locations (1)

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