Modified Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection
关键词
抽象
描述
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.
日期
| 最后验证: | 12/31/2019 |
| 首次提交: | 01/03/2018 |
| 提交的预估入学人数: | 01/09/2018 |
| 首次发布: | 01/10/2018 |
| 上次提交的更新: | 01/17/2020 |
| 最近更新发布: | 01/21/2020 |
| 实际学习开始日期: | 04/08/2018 |
| 预计主要完成日期: | 12/30/2019 |
| 预计完成日期: | 12/30/2019 |
状况或疾病
干预/治疗
Procedure: Vagus nerve-preserving group
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Delayed gastric emptying [1 year]
次要成果指标
1. Postoperative complications of the digestive system [1 year]
2. Body weight [1 year]
3. Hepatic decompensation [1 year]
4. Portal vein system thrombosis [1 year]
5. Hepatocellular carcinoma [1 year]
6. Overall survival [1 year]
