Laparoscopic Splenectomy and Azygoportal Disconnection With Intraoperative Endoscopic Variceal Ligation (SVEL)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Cirrhosis; Laparoscopy; Splenectomy
• Intervention / Treatment: Procedure: laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225001
      • Clinical Medical College, Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intraoperative endoscopic variceal ligation group; 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	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.
No Intervention: Non-intraoperative endoscopic variceal ligation group; Every patient of conventional group will receive single vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection without intraoperative endoscopic variceal ligation procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esophageal variceal re-bleeding	Proportions of patients who will suffer from esophageal variceal re-bleeding	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death due to re-bleeding	Proportions of patients who will suffer from death due to re-bleeding	1 year
Overall survival	Overall survival in both groups	1 year

Collaborators and Investigators

• Sponsor: Northern Jiangsu People's Hospital
• Investigators: Study Chair: Luo-Jing Zhou, MD, Clinical Medical College, Yangzhou University

Publications and helpful links

General Publications

• Bai DS, Jin SJ, Xiang XX, Qian JJ, Zhang C, Zhou BH, Gao TM, Jiang GQ. Vagus Nerve-Preserving Laparoscopic Splenectomy and Azygoportal Disconnection with Versus Without Intraoperative Endoscopic Variceal Ligation: a Randomized Clinical Trial. J Gastrointest Surg. 2022 Sep;26(9):1838-1845. doi: 10.1007/s11605-022-05374-1. Epub 2022 Jun 8.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 18, 2020
• First Submitted That Met QC Criteria: January 26, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; laparoscopy; Cirrhosis; Vagus nerve; Esophageal variceal re-bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Fibrosis; Hypertension
• Other Study ID Numbers: YZUC-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No