The Effect of Application of TachoSil® in Pancreatoduodenectomy

Asan Medical Center

Status and phase: Unknown; Phase 4

Conditions: Pancreatic Periampullary Cancer; Pancreatic Bordeline Tumor; Pancreatic Neoplasm

Treatments: Drug: Fibrinogen/thrombin-coated collagen patch

Study type: Interventional

Funder types: Other

Identifiers

NCT03269955

2016-0791

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

application of TachoSil®

Experimental group

Description:

Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy

Treatment:

Drug: Fibrinogen/thrombin-coated collagen patch

control

No Intervention group

Description:

Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy.