The Impact of External Pancreatic Drainage During Pancreaticojejunostomy Following Pancreaticoduodenectomy in Cases of Soft Pancreas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- evidence of pancreatic fistula
研究概览
简要总结
Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.
详细描述
The role of external pancreatic duct drainage in managing patients with a soft pancreas is particularly important, as these patients are at a heightened risk of developing postoperative complications. By providing an external route for pancreatic secretions, external pancreatic duct drainage may help to reduce the enzymatic activity at the anastomosis site and promote better healing.
In addition to reducing the incidence of post operative pancreatic fistula, external pancreatic duct drainage may have other potential benefits, such as decreasing the length of hospital stay, reducing the need for additional interventions, and improving overall patient quality of life. However, these potential benefits must be weighed against the risks and drawbacks of external pancreatic duct drainage, including the potential for stent-related complications and the need for an additional procedure to remove the stent.
•After being informed about the study and potential risks, all patients giving written consent. Patients who meet the eligibility requirements will be randomized in a 1:1 ratio to external pancreatic drainage group and no external pancreatic drainage group.
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
- Single (Outcomes Assessor)
盲法说明
Surgeons are not blinded due to the intervention's nature; data collectors, assessors, and analysts are blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing pancreaticoduodenectomy (Whipple procedure) for various indications (e.g., pancreatic cancer, ampullary cancer, etc.).
- •Patients with a confirmed soft pancreas texture, as determined intraoperatively by the surgeon.
排除标准
- •Patients with a hard or fibrotic pancreas, as determined intraoperatively by the surgeon.
- •Patients with severe uncontrolled comorbidities (e.g., uncontrolled diabetes, severe cardiovascular disease, renal failure).
- •Pregnancy or lactation.
研究组 & 干预措施
Pancreaticojejunostomy with External stent
ureteric catheter (7Fr) insert at pancreatojejunostomy site as a stent. And stent tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall.
干预措施: Pancreaticojejunostomy with external stent (Procedure)
Pancreaticojejunostomy without stent
Pancreaticojejunostomy without stent
干预措施: Pancreaticojejunostomy without external stent (Procedure)
结局指标
主要结局
evidence of pancreatic fistula
时间窗: within the first 7 days after surgery( first day, third day and fifth day)
confirmed by serum and drain amylase
次要结局
- evidence of intra abdominal collection(first week, second week postoperative)
研究者
Saleh Khairy Saleh MD
Lecturer
Minia University