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Trial record 43 of 43 for:    Recruiting, Not yet recruiting, Available Studies | "Gastroparesis"

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

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ClinicalTrials.gov Identifier: NCT03396796
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Guo-Qing Jiang, Yangzhou University

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


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.



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396796


Contacts
Contact: Guo-Qing Jiang, MD 86-514-87373272 jgqing2003@hotmail.com
Contact: Dou-sheng Bai, MD 86-514-87373275 bdsno1@hotmail.com

Locations
China, Jiangsu
Clinical Medical College of Yangzhou University Recruiting
Yangzhou, Jiangsu, China, 225001
Contact: Guo-Qing Jiang, MS    86-514-87373372    jgqing2003@hotmail.com   
Contact: Dou-Sheng Bai, MD    86-514-87373375    bdsno1@hotmail.com   
Principal Investigator: Guo-Qing Jiang, MD         
Sub-Investigator: Sheng-Jie Jin, MD         
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

Responsible Party: Guo-Qing Jiang, Clinical Professor, Yangzhou University
ClinicalTrials.gov Identifier: NCT03396796     History of Changes
Other Study ID Numbers: YZUC-003
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

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