- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03396796
Modified Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection (ESVLSD)
January 18, 2020 updated by: Guo-Qing Jiang, Yangzhou University
Modified Vagus Nerve-preserving Versus Conventional 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Yangzhou, Jiangsu, China, 225001
- Clinical Medical College of Yangzhou University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delayed gastric emptying
Time Frame: 1 year
|
Proportions of patients who will suffer from delayed gastric emptying in both groups.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Body weight
Time Frame: 1 year
|
Proportions of patients who will show improvement in body weight both groups.
|
1 year
|
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.
|
1 year
|
Portal vein system thrombosis
Time Frame: 1 year
|
Proportions of patients who will suffer from portal vein system thrombosis in both groups.
|
1 year
|
Hepatocellular carcinoma
Time Frame: 1 year
|
Proportions of patients who will suffer from hepatocellular carcinoma in both groups.
|
1 year
|
Overall survival
Time Frame: 1 year
|
Overall survival in both groups.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University
- Study Director: Ping Chen, MD, Clinical Medical College of Yangzhou University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 9, 2018
Primary Completion (ACTUAL)
December 31, 2019
Study Completion (ACTUAL)
December 31, 2019
Study Registration Dates
First Submitted
January 4, 2018
First Submitted That Met QC Criteria
January 10, 2018
First Posted (ACTUAL)
January 11, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 18, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YZUC-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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