Efficacy of Pancreatic Parenchymal N-Butyl-2-Cyanoacrylate Injection in Pancreaticojejunostomy After Pancreaticoduodenectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of postoperative pancreatic fistula
研究概览
简要总结
This randomized controlled trial investigates the safety and efficacy of injecting N-butyl-2- cyanoacrylate (Histoacryl®) into the pancreatic parenchyma during pancreaticoduodenectomy (PD) to enhance the security of the pancreaticojejunostomy (PJ) anastomosis and reduce postoperative pancreatic fistula (POPF) rates.
详细描述
This randomized controlled trial aims to evaluate the efficacy of pancreatic parenchymal N-Butyl-2-Cyanoacrylate (NBCA) injection in reducing the incidence and severity of postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy (PD). POPF remains a major complication of PD, leading to increased morbidity, mortality, and healthcare costs. NBCA, a tissue adhesive, has shown promise in various surgical applications due to its hemostatic and sealing properties. This study will enroll approximately 90 patients undergoing PD, randomly assigning them to either the NBCA injection group or the control group. The primary outcome will be the incidence of POPF according to the International Study Group on Pancreatic Surgery (ISGPS) definition. Secondary outcomes includes length of hospital stay, readmission rates, reoperation rates, mortality, and other postoperative complications. This trial is designed to provide high level evidence regarding the utility of NBCA in improving outcomes after PD.
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)
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 for malignant lesions meeting the curative treatment intent in accordance with clinical guidelines.
- •Soft pancreatic texture.
- •Small main pancreatic duct diameter (<3 mm).
- •Informed consent obtained.
排除标准
- •Known hypersensitivity to cyanoacrylate or Lipiodol®.
- •Extremely hard, fibrotic pancreas.
- •Significant pancreatitis involving the pancreatic remnant.
- •Active infection at the surgical site.
- •Uncontrolled coagulopathy.
- •Unfit patients for surgery due to severe medical illness.
- •Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
- •Irresectable tumors in diagnostic laparoscopy.
- •Patients requiring left, central or total pancreatectomy or other palliative surgery.
- •Pregnant or breastfeeding women.
- •Patients with serious mental disorders.
- •Patients with vascular invasion and requiring vascular resection.
- •Patients refused to participate in the study.
研究组 & 干预措施
N-butyl-2-cyanoacrylate (Histoacryl® )Injection Group.
Patients randomized to this group will undergo pancreaticoduodenectomy and pancreaticojejunostomy with pancreatic parenchymal injection of N-butyl-2-cyanoacrylate during pancreaticoduodenectomy.
干预措施: Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group. (Drug)
Standard Pancreaticojejunostomy
Patients randomized to this group will undergo pancreaticoduodenectomy and pancreaticojejunostomy using the standard surgical technique of the institution, without the application of N-Butyl-2-Cyanoacrylate or any other sealant to the pancreatic anastomosis. No placebo injection will be administered.
干预措施: Standard Pancreaticojejunostomy (Procedure)
结局指标
主要结局
Incidence of postoperative pancreatic fistula
时间窗: Up to 90 days post-surgery
A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day.
次要结局
- Incidence of postoperative acute pancreatitis(1 day post index surgery)
- Incidence of Post-Pancreatectomy Hemorrhage(90 days)
- Incidence of intra-abdominal abscess(90 days)
- Incidence of biliary fistula(90 days)
- Rate of readmission(30 days after hospital discharge)
研究者
Saleh Khairy Saleh MD
Lecturer
Minia University