Laparoscopic Splenectomy and Azygoportal Disconnection With Intraoperative Endoscopic Variceal Ligation

NCT04244487 | Completed

• 1 other identifier: YZUC-004
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Hypertension; Splenectomy; Laparoscopy

Keywords

Vagus nerve; Esophageal variceal re-bleeding; Cirrhosis; Hypertension; laparoscopy

Outcome Measures

Primary Outcomes (1)

• Esophageal variceal re-bleeding

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

  1 year

Secondary Outcomes (2)

• Death due to re-bleeding

  1 year

• Overall survival

  1 year

Study Arms (2)

intraoperative endoscopic variceal ligation group

EXPERIMENTAL

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

Non-intraoperative endoscopic variceal ligation group

NO INTERVENTION

Every patient of conventional group will receive single vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection without intraoperative endoscopic variceal ligation procedure

Interventions

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.

intraoperative endoscopic variceal ligation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, 225001, China

Location

Related Publications (1)

• 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.

  PMID: 35676457 DERIVED

MeSH Terms

Conditions

Fibrosis; Hypertension

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Luo-Jing Zhou, MD

  Clinical Medical College, Yangzhou University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 28, 2020
• Study Start: January 3, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)