Pancreaticojejunostomy With or Without Modified N-butyl-2-cyanoacrylate Following Pancreaticoduodenectomy in Soft Pancreas: Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Pancreatic Fistula (POPF).
研究概览
简要总结
This is a single-center, randomized controlled trial comparing the efficacy of pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate(Glubran® 2) versus standard pancreaticojejunostomy without cyanoacrylate in preventing postoperative pancreatic fistula (POPF) in patients undergoing pancreaticoduodenectomy with soft pancreatic texture. The primary endpoint is the incidence of postoperative pancreatic fistula at 30 days post-surgery, as defined by the International Study Group on Pancreatic Fistula (ISGPF) criteria.Secondary outcomes include surgical complications and length of hospital stay. The study will enroll approximately 194 patients at a single center.
详细描述
Postoperative pancreatic fistula (POPF) remains the most common and serious complication following pancreaticoduodenectomy, with incidence rates reaching up to 56.7% in patients with soft pancreatic texture. The soft pancreatic parenchyma is particularly vulnerable to anastomotic breakdown due to its friable nature and difficulty in achieving secure suturing.
N-butyl-2-cyanoacrylate is a biodegradable tissue adhesive that polymerizes rapidly upon contact with hydroxide ions in tissue fluids, forming a strong, flexible bond. The application of modified N-butyl-2-cyanoacrylate to pancreaticoenteric anastomoses may reduce the incidence of POPF by providing additional mechanical reinforcement and sealing of minor leaks.
This is a phase III, single-center, prospective, randomized controlled trial with parallel groups. Eligible patients will undergo intraoperative assessment of pancreatic texture (soft confirmed by surgeon's palpation). Randomization will occur intraoperatively after resection but before reconstruction, using computer-generated blocks.
This study aims to evaluate whether the application of modified N-butyl-2-cyanoacrylate (Glubran® 2) during pancreaticojejunostomy can significantly reduce the incidence of POPF in patients with soft pancreatic texture undergoing pancreaticoduodenectomy. Patients will be randomized to receive either standard pancreaticojejunostomy (control group) or pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate application (intervention group).
The intervention group will receive 1-2 mL of modified N-butyl-2-cyanoacrylate applied topically to the pancreatic stump and anastomosis site during pancreaticojejunostomy. The control group will receive standard duct-to-mucosa pancreaticojejunostomy without adhesive. All patients will receive standardized perioperative care, including prophylactic antibiotics and drain management per ISGPF guidelines.
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 (Outcomes Assessor)
盲法说明
The operating surgeon and patient cannot be blinded due to the nature of the intervention. However, outcome assessors, including radiologists reviewing imaging studies and physicians evaluating postoperative complications, will be blinded to treatment allocation.
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 scheduled for elective pancreaticoduodenectomy for malignant lesions.
- •Intraoperative confirmation of soft pancreatic texture (by surgeon palpation; friable, non-fibrotic pancreas).
- •Age 18-75 years .
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Adequate organ function defined as:
- •Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count ≥ 1,500/μL Platelet count ≥ 100,000/μL Total bilirubin ≤ 3 times upper limit of normal Alanine transaminase (ALT) /Alanine transaminase (ALT)( ≤ 5 times upper limit of normal Serum creatinine ≤ 1.5 times upper limit of normal
- •Informed consent provided.
- •Willingness to comply with study procedures and follow-up requirements.
排除标准
- •Hard pancreatic texture (intraoperative surgeon assessment).
- •Emergency surgery.
- •Previous pancreatic surgery or pancreatic anastomosis.
- •Intraoperative identification of unresectable disease
- •Known allergy to cyanoacrylate or components.
- •Pregnancy or lactation.
- •Active infection or sepsis.
- •Inability to comply with follow-up.
研究组 & 干预措施
Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)
Patients undergo standard duct-to-mucosa pancreaticojejunostomy with topical application of 1-2 mL modified N-butyl-2-cyanoacrylate to the anastomotic site and surrounding pancreatic parenchyma.
干预措施: Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) (Drug)
Standard Pancreaticojejunostomy without tissue adhesive application.
Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy.
干预措施: Standard(duct-to-mucosa) Pancreaticojejunostomy (Procedure)
结局指标
主要结局
Incidence of Postoperative Pancreatic Fistula (POPF).
时间窗: 30 days post-surgery.
Percentage of patients developing postoperative pancreatic fistula as defined by International Study Group on Pancreatic Fistula (ISGPF) criteria. POPF is defined as drain output of any measurable volume of fluid on or after postoperative day 3 with amylase content greater than 3 times the upper normal serum value. Graded as A (biochemical leak), B , or C.
次要结局
- Time to POPF resolution.(90 days post-surgery.)
- Postoperative complications(30 days post-surgery)
- Reoperation Rate(90 days post-surgery.)
- Length of Hospital Stay(Up to 90 days)
- Incidence of postpancreatectomy Hemorrhage(30 days post-surgery)
- Mortality Rate(90 days post-surgery)
研究者
Saleh Khairy Saleh MD
Lecturer
Minia University