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NCT Number: NCT04244487

Laparoscopic Splenectomy and Azygoportal Disconnection With 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.

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Key information

Conditions

Cirrhosis Cardiovascular Diseases Fibrosis Hypertension Laparoscopy Pathologic Processes Pathological Conditions, Signs and Symptoms Splenectomy Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, 225001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation

Procedure

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.

Primary outcomes

  1. Esophageal variceal re-bleeding

    Time frame: 1 year

    Proportions of patients who will suffer from esophageal variceal re-bleeding

Secondary outcomes

  1. Death due to re-bleeding

    Time frame: 1 year

    Proportions of patients who will suffer from death due to re-bleeding

  2. Overall survival

    Time frame: 1 year

    Overall survival in both groups

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

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

Acronym: SVEL

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2020
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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