Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System
研究概览
简要总结
The investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm).
详细描述
Pancreatic leak remains a significant cause of morbidity and extra cost following distal pancreatectomy. Historically, previous attempts to reduce the leak rate have met with limited success. To examine this problem the investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm). A drain will be placed in the left upper quadrant at the time of resection. Drainage of the pancreatic resection bed is widely accepted and remains our current standard of care.
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
- Single (Participant)
盲法说明
Participant's were blinded to the results of the randomization for 6 weeks.
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
- •Participants must be 18 years or older and able to give consent. Any patient undergoing a distal pancreatectomy, laparoscopic or open, will be eligible for randomization.
- •No exclusion is provided for primary diagnosis. In the event of a patient undergoing a planned resection of another organ or organs with only a possibility of a distal pancreatic resection (i.e. colectomy, hepatectomy, gastrectomy, nephrectomy), the patient will still be eligible for inclusion in the study. We expect that some patients will be randomized but not resected (ie metastasis identified). A few patients may not be stapled using the study device for technical reasons (ie the stapler does not fit). The data will be analyzed in an intent-to-treatment approach.
排除标准
- •None specified
研究组 & 干预措施
Stapled transection without mesh reinforcement
Stapled transection with mesh reinforcement
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
干预措施: Mesh reinforced staple line (SEAMGUARD) (Device)
Stapled transection with mesh reinforcement
Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
干预措施: Stapled without mesh reinforcement (PER-STRIPS DRY) (Device)
结局指标
主要结局
Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System
时间窗: 100 days or removal of drain
* Identified as being a grade B or grade C fistula or any fistula that altered the patients' management in any way * Determination of severity of pancreatic fistula was done using the ISGPF(International Study Group Pancreatic Fistula) leak/fistula/pancreatic occlusion failure * Grade B: \>3x normal serum amylase, often well clinical condition, yes/no specific treatment, negative/positive ultrasound/CT, usually persistent drainage (\>3 weeks), yes/no signs of infection, yes/no readmission, no sepsis, no reoperation, no death related to fistula * Grade C: \>3x normal serum amylase, ill appearing/bad, requires specific treatment, positive ultrasound/CT, persistent drainage (\>3 weeks), signs of infection, yes/no readmission, sepsis, reoperation, and death related to fistula
次要结局
- Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System(100 days or removal of drain)
- Time to Drain Removal(100 days or removal of drain)
- Number of Non-pancreatic Adverse Events(100 days or removal of drain)