Clinical trial NCT03396796: Modified Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection
Official title: Modified Vagus Nerve-preserving Versus Conventional Laparoscopic Splenectomy and Azygoportal Disconnection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Hypertension
Splenectomy
Laparoscopy
Keywords: Vagus nerve
Delayed gastric emptying
Cirrhosis
Hypertension
laparoscopy
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Delayed gastric emptying
timeFrame: 1 year
Secondary outcomes:
measure: Postoperative complications of the digestive system
timeFrame: 1 year
measure: Body weight
timeFrame: 1 year
measure: Hepatic decompensation
timeFrame: 1 year
measure: Portal vein system thrombosis
timeFrame: 1 year
measure: Hepatocellular carcinoma
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Clinical Medical College of Yangzhou University
state: Jiangsu
Study officials:
affiliation: Clinical Medical College of Yangzhou University
name: Dou-Sheng Bai, MD
role: STUDY_CHAIR
affiliation: Clinical Medical College of Yangzhou University
name: Guo-Qing Jiang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Medical College of Yangzhou University
name: Ping Chen, MD
role: STUDY_DIRECTOR
References: