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Completed

NCT Number: NCT03396796

Modified Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

About this study

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.

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
  • 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

Treatment and study plan

Vagus nerve-preserving group

Procedure

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.

Primary outcomes

  1. Delayed gastric emptying

    Time frame: 1 year

    Proportions of patients who will suffer from delayed gastric emptying in both groups.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Official study title

Modified Vagus Nerve-preserving Versus Conventional Laparoscopic Splenectomy and Azygoportal Disconnection

Acronym: ESVLSD

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2018
Registry last updated
Jan 22, 2020

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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