The Effect of Application of TachoSil® in Pancreatoduodenectomy

The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.)