Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Composite endpoint comparison
研究概览
简要总结
The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether the omission of routine intraperitoneal drainage in the setting of reinforced staple technology is non-inferior to routine intraperitoneal drainage with respect to a composite post-operative complications of Grade B or C Postoperative pancreatic fistula (POPF), readmission, or organ space surgical site infection following a distal pancreatectomy.
详细描述
Pancreatic resections are commonly performed across the United States, yet still represent one of the most morbid abdominal operations in the country, with postoperative mortality as high as 7.7%. Distal pancreatectomy (DP) represents one of the most common approaches to pancreatic resection and is typically used for tumors of the pancreatic body or tail. This operation is known to have a high historic morbidity, with reports of overall morbidity between 12-52%. Common complications include intraabdominal abscess and surgical site infection. Postoperative pancreatic fistula (POPF) represents the most common complication following partial pancreatic resection, with rates reported with rates as high as 30% in multiple large retrospective studies. Multiple strategies to prevent postoperative pancreatic leak following distal pancreatectomy have been studied. One of the outstanding questions that remains is regarding the need for routine intraperitoneal drainage following DP, particularly since the advent of reinforced staple technology. This study aims to determine if intraperitoneal drainage is necessary following DP. This study will compare groups using a composite endpoint of complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)
- •Age ≥18 years
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients < 18 years old
- •Patients who are pregnant
- •Patients with a history of previous pancreatic surgery
- •Patients with a history of prior gastric resection, gastric bypass or sleeve gastrectomy
- •Patients with prior cystogastrostomy procedure
- •Patients who have failed prior endoscopic intervention or ultrasound due to esophageal or other gastrointestinal stricture
- •Patients with Type 3 or Type 4 Paraesophageal Hernia noted either on pre-operative imaging or intra-operatively
- •Patients undergoing concurrent resection of organs other than the pancreas or spleen or gallbladder
- •Patients who undergo oversewing of the pancreatic transection margin
- •Patients with unexpected intraoperative bleeding or adhesive disease which deem it unsafe to proceed without an intraabdominal drain
- •Patients who are unable to provide informed consent
研究组 & 干预措施
Standard of care
Intraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care.
干预措施: 19 French Blake Drain (Device)
Omitting Standard of Care
No intraperitoneal drain will be placed in the participants, which omits the routine standard of care.
结局指标
主要结局
Composite endpoint comparison
时间窗: Within 90 days of surgery
Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF
次要结局
- Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF(90-day post operative time point)
- Cost analysis for overall healthcare costs(At day 90 postoperative)
- Hospital Length of Stay(90-day post operative time point)
- Quality of Life Score(At day 90 postoperative)
- Quality of Life Score(At day 14 postoperative)