Cirrhosis, Hypertension, Laparoscopy, Splenectomy
Conditions
Keywords
Vagus nerve, Delayed gastric emptying, Cirrhosis, Hypertension, laparoscopy
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.
Interventions
PROCEDUREVagus 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.
Sponsors
Yangzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delayed gastric emptying | 1 year | Proportions of patients who will suffer from delayed gastric emptying in both groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 1 year | Proportions of patients who will show improvement in body weight both groups. |
| Hepatic decompensation | 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. |
| Postoperative complications of the digestive system | 1 year | Proportions of patients who will suffer from postoperative complications of the digestive system in both groups. |
| Hepatocellular carcinoma | 1 year | Proportions of patients who will suffer from hepatocellular carcinoma in both groups. |
| Overall survival | 1 year | Overall survival in both groups. |
| Portal vein system thrombosis | 1 year | Proportions of patients who will suffer from portal vein system thrombosis in both groups. |
Countries
China
Outcome results
None listed