Modified Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection (ESVLSD)

• ClinicalTrials.gov Identifier: NCT03396796
• Recruitment Status: Completed
• First Posted: January 11, 2018
• Last Update Posted: January 22, 2020
• Sponsor: Yangzhou University
• Information provided by (Responsible Party): Guo-Qing Jiang, Yangzhou University

Study Description

Brief Summary:

This study aimed to evaluate whether vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection is effective and safe, and to determine whether a reduction in the incidence of postoperative complications of the digestive system improves postoperative quality of life compared with conventional laparoscopic splenectomy and azygoportal disconnection.

Condition or disease	Intervention/treatment	Phase
Cirrhosis; Hypertension; Splenectomy; Laparoscopy	Procedure: Vagus nerve-preserving group	Not Applicable

Detailed Description:

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline parameter will be recorded and the patient will be randomized into either interventional (vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection) or control (conventional laparoscopic splenectomy and azygoportal disconnection) 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, 9, and 12 after operation, electron gastroscopy examination for delayed gastric emptying will be done for all patients. Postoperative complications of the digestive system (including diarrhea, epigastric fullness, bloating, nausea, and vomiting), liver and renal function, and body weight will be recorded at the seventh day, months 1, 3, 6, 9, and 12 after operation. Then one year monitoring will be done in the both groups as per the primary or secondary outcome.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Modified Vagus Nerve-preserving Versus Conventional Laparoscopic Splenectomy and Azygoportal Disconnection
• Actual Study Start Date: April 9, 2018
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vagus nerve-preserving group; Every patient of vagus nerve-preserving group will receive the modified vagus nerve-preserving laparoscopic azygoportal disconnection procedure.	Procedure: Vagus nerve-preserving group; The modified vagus nerve-preserving procedure was performed in the following order: (1) left gastroepiploic vein along greater curvature; (2) the posterior surface of stomach, including the posterior gastric veins; (3) the left lateral surface of the distal esophagus; (4) the left inferior phrenic veins; (5) the posterior surface of the distal esophagus;(6) the anterior surface of the distal esophagus; and (7) the right lateral surface of the distal esophagus. The hepatogastric ligament was conserved. the adherent junction between visceral peritoneum and the right crural diaphragm, and divided it into the lesser omental sac. The left gastric artery and vein and the posterior gastric veins were transected en bloc using a linear laparoscopic vascular stapler.
No Intervention: Conventional group; Every patient of conventional group will receive the conventional laparoscopic azygoportal disconnection procedure.

Outcome Measures

Primary Outcome Measures :

1. Delayed gastric emptying [ Time Frame: 1 year ]
   Proportions of patients who will suffer from delayed gastric emptying in both groups.

Secondary Outcome Measures :

1. Postoperative complications of the digestive system [ Time Frame: 1 year ]
   Proportions of patients who will suffer from postoperative complications of the digestive system in both groups.
2. Body weight [ Time Frame: 1 year ]
   Proportions of patients who will show improvement in body weight both groups.
3. Hepatic decompensation [ Time Frame: 1 year ]
   Proportions of patients who will suffer from hepatic decompensation defined as development of ascites, PSE, portal hypertensive bleeding, jaundice, spontaneous bacterial peritonitis, or systemic infection.
4. Portal vein system thrombosis [ Time Frame: 1 year ]
   Proportions of patients who will suffer from portal vein system thrombosis in both groups.
5. Hepatocellular carcinoma [ Time Frame: 1 year ]
   Proportions of patients who will suffer from hepatocellular carcinoma in both groups.
6. Overall survival [ Time Frame: 1 year ]
   Overall survival in both groups.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
• Splenomegaly with secondary hypersplenism
• Bleeding portal hypertension
• No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT
• Informed consent to participate in the study

Exclusion Criteria:

• Delayed gastric emptying
• Diarrhea
• 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

Contacts and Locations

Locations

China, Jiangsu

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, China, 225001

Sponsors and Collaborators

Yangzhou University

Investigators

• Study Chair: Dou-Sheng Bai, MD; Clinical Medical College of Yangzhou University
• Principal Investigator: Guo-Qing Jiang, MD; Clinical Medical College of Yangzhou University
• Study Director: Ping Chen, MD; Clinical Medical College of Yangzhou University

More Information

• Responsible Party: Guo-Qing Jiang, Clinical Professor, Yangzhou University
• ClinicalTrials.gov Identifier: NCT03396796
• Other Study ID Numbers: YZUC-003
• First Posted: January 11, 2018
• Last Update Posted: January 22, 2020
• Last Verified: January 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guo-Qing Jiang, Yangzhou University:

Vagus nerve; Delayed gastric emptying; Cirrhosis; Hypertension; laparoscopy

Additional relevant MeSH terms:

Hypertension; Fibrosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes