NCT03269955

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Neoplasm
• Pancreatic Periampullary Cancer
• Pancreatic Bordeline Tumor

Interventions

Type	Name	Description
DRUG	Fibrinogen/thrombin-coated collagen patch	Tachosil® is cut in half and applied to the front and back of the pancreaticojejunostomy respectively, and fibrin glue is applied on it

Timeline

• Start date: 2017-02-27
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2017-09-01
• Last updated: 2017-09-01

Locations

1 site across 1 country: South Korea