Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma: Multicenter Randomized Double-blind Placebo Controlled Trial (SOMAPROTECT01)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 7
- 主要终点
- presence of postoperative ascites during the postoperative course
研究概览
简要总结
Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, with subsequent morbidity, liver and renal failure, the need for specific treatments and prolonged hospital stay. Postoperative ascites is favored by an imbalance between portal venous inflow and the diminished hepatic venous outflow. Finding a reversible, non-invasive method for modulating the portal inflow would be of interest: it could be used temporarily during the early postoperative course to prevent acute portal hypertension. Somatostatin, a well-known drug already used in several indications, may limit the risk of postoperative ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in patients with underlying liver disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HCC diagnosed by histology or by imaging findings according to the Barcelona Clinic Liver Cancer Group
- •Patients with a single or multiple HCCs deemed to be resectable with a curative intent at the preoperative evaluation
- •Patients for whom an indication for hepatectomy has been decided and approved by multidisciplinary board:
- •by laparotomy
- •by coelioscopy with resection of at least 2 liver segments
- •Patients with any underlying liver disease with or without proven cirrhosis, regarding histological features (including F2-F3-F4 fibrosis with or without cirrhosis) or with other evidence of a diseased liver if no biopsy has been performed preoperatively (dysmorphic liver or evidence of portal hypertension at imaging findings, oesophageal varices at endoscopy)
- •Age ≥ 18 years
- •Patients with ability to understand and sign a written inform consent form
- •Patients who will be available for follow-up
排除标准
- •Patients participating in another interventional research in progress or including an exclusion period still in progress at pre-inclusion (except interventional research with minimal risks and constraints that do not interfere with the judgement criteria of the study according to the judgement of the coordinating investigator).
- •Patients with evidence of a healthy liver at biopsy
- •Disease-associated non-inclusion criteria include:
- •Another histologic type of hepatic tumor besides HCC
- •Distant extra-hepatic metastases, including peritoneal carcinomatosis
- •The existence of complete portal thrombosis of the main portal trunk
- •Operative technique-associated non-inclusion criteria include:
- •- Indication of coelioscopy with resection of less than 2 liver segments
研究组 & 干预措施
Experimental group
postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day
干预措施: somatostatin infusion (Drug)
Control group
Placebo infusion (50ml of 0.9% NaCl/day) during 6 days
干预措施: placebo infusion (Drug)
结局指标
主要结局
presence of postoperative ascites during the postoperative course
时间窗: Day 90
The presence of postoperative ascites during the postoperative course defined by: * ≥500 ml / 24h of fluid in the drains during at least 3 days. Or * ascites requiring puncture or drainage
次要结局
- postoperative morbidity(Day 90)
- Postoperative morbidity on Renal failure(Day 90)
- Duration of ascites(Day 90)
- Volume of ascites(Day 90)
- Postoperative morbidity on Liver failure(Day 90)