Comparison of Resection During Distal Pancreatectomy of the Splenic Vein Either Together With the Pancreatic Parenchyma or After Isolation: A Multicentre, Prospective, Randomized Phase III Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- the incidence of pancreatic fsitula grade B/C
研究概览
简要总结
Eligible patients will be centrally randomized to either Arm A (resection of the splenic vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together with the pancreas).
详细描述
In distal pancreatectomy, it is customary to ligate and divide the splenic vein after isolating it from the pancreatic parenchyma. This is considered essential to prevent disruption of the stump of the splenic vein and the consequent intra-abdominal haemorrhage in the event of pancreatic fistula. This procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of this trial is to confirm the non-inferiority of resection of the splenic vein embedded in the pancreatic parenchyma compared with the conventional technique of isolating the splenic vein before resection during distal pancreatectomy using a mechanical stapler.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective open or laparoscopic distal pancreatectomy for diseases of the pancreatic body and tail
- •ECOG Performance Status (PS) = 0-1
- •Age ≥ 20 years old
- •Maintenance of functioning of the major organs (bone marrow, liver, kidney, lung, etc.) (a) White blood cells ≥ 2,500/mm3 (b) Haemoglobin ≥ 9.0 g/dL (c) platelets ≥ 100,000/mm3 (d) Total bilirubin ≤ 2.0 mg/dL (e) Creatinine ≤ 2.0 mg/dL (v) Sufficient judgement to understand the study and to provide written informed consent
排除标准
- •Splenic vein-preserving distal pancreatectomy
- •Superior mesenteric vein or portal vein invasion
- •Pancreatic trauma
- •Preoperative inflammatory pancreatic disease (pancreatitis)
- •Requirement of anti-coagulant treatment during or after surgery. Anti-coagulant treatment at 24 hrs after surgery is allowed.
- •Severe ischemic cardiovascular disease
- •Liver cirrhosis or active hepatitis
- •Need for oxygen due to interstitial pneumonia or lung fibrosis
- •Dialysis due to chronic renal failure
- •Need for surrounding organ resection (stomach, colon, etc.), excluding the left adrenal gland and gall bladder
- •Active multiple cancer that is thought to influence the occurrence of adverse events
- •Difficulty with study participation due to psychotic disease or symptoms
- •Inappropriate use of the stapler
- •Inappropriate for the study objectives
结局指标
主要结局
the incidence of pancreatic fsitula grade B/C
时间窗: 6 months after operation
次要结局
- thickness of the resected pancreatic parenchyma(during operation)
- haemostasis of the staple line(during operation)
- the incidence of pancreatic injury(during operation)
- need for additional sutures to securely close the pancreatic stump(during operation)
- duration of drainage tube placement(6 months after operation)
- the incidence of pancreatic fsitula of all grades(6 months after operation)
- the incidence of thrombosis of the splenic vein(6 months after operation)
- integrity of the staple line(during operation)
- mortality(6 months after operation)
- the operative time(during operation)
- postoperative hospital stay duration(6 months after operation)
- the incidence of conversion from laparoscopic surgery to open surgery(during operation)
- the incidence of pancreatic fsitula grade C(6 months after operation)
- volume of blood loss(during operation)
- the incidenceof intra-abdominal haemorrhage(6 months after operation)
- the incidence of all complications(6 months after operation)
- comparison of the thickness of the resected pancreatic parenchyma with the incidence of PF grade B/C(6 months after operation)
- time needed for pancreatic transection(during operation)
研究者
Hiroki Yamaue
Professor
Wakayama Medical University