The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy
试验速览
- 阶段
- 4 期
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Incidence of clinically relevant pancreatic fistula
研究概览
简要总结
Fibrinogen/thrombin-coated collagen patch (TachoSil®) is known to have the effect of strengthening tissue anastomosis and promoting suturing to prevent leakage. The purpose of this study is to compare the incidence of pancreatic fistula that is most crucial for surgical outcome and complications in pancreaticoduodenectomy with those of the control group and the TachoSil® apply group.
Patients who were planned to undergo pancreaticoduodenectomy without a history of chronic pancreatitis are enrolled in this open-label, single-center, randomized, single-blind, phase 4 clinical trial.
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 (Participant)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance score of 0-2
- •Periampulary cancer or borderline tumor that is able to resection on preoperative examination
- •Patients without distance metastasis
- •Bone marrow function: WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
- •Liver function: AST/ALT less than 3 times upper limit of normal
- •Kidney function: Creatinine no greater than 1.5 times upper limit of normal
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with distant metastases are not eligible
- •Recurred periampulary cancer
- •Pregnant and breastfeeding women
- •Patients with active or uncontrolled infection
- •Patients with uncontrolled heart disease
- •Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (Liver cirrhosis, chronic kidney failure, heart failure, etc.)
- •Patients who underwent other major abdominal organs surgery except for scheduled pancreatoduodenectomy (gastrectomy, colonic resection, etc.)
研究组 & 干预措施
application of TachoSil®
Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy
干预措施: Fibrinogen/thrombin-coated collagen patch (Drug)
结局指标
主要结局
Incidence of clinically relevant pancreatic fistula
时间窗: At 5 days after surgery
The grade uses ISGPF grading, while the grades B and C are clinically relevant pancreatic fistula. All patients underwent abdominal CT at 5 days postoperatively for grade evaluation.
Incidence of pancreatic fistula
时间窗: At 3 days after surgery
The evaluation of the pancreatic fistula was based on the international study group of pancreatic fistula (ISGPF). According to the criteria, evaluation of pancreatic fistula was evaluated by measuring the amylase level of the drain tube on the third postoperative day, and the pancreatic fistula was judged to be present when the amylase level was three times higher than the normal level of the amylase in the blood.
次要结局
- Incidence of complication except for pancreatic fistula(Through study completion, an average of 1 year)
- Removal time of drainage(From date of surgery until the date of the last drainage removal, whichever came first, assessed up to study completion, an average of 1 year)
- Death(From date of surgery to 30 days after discharge)
- Re-admission rate(Through study completion, an average of 1 year)
- Period of hospitalization after surgery(From date of surgery until the date of discharge, whichever came first, assessed up to study completion, an average of 1 year)
研究者
Jae Hoon Lee
M.D, Ph.D
Asan Medical Center