None listed
Conditions
Interventions
Trade Name: TACHOSIL*1SPUGNA 9,5CMx4,8CM
Pharmaceutical Form: Impregnated pad
INN or Proposed INN: FIBRINOGENO UMANO
INN or Proposed INN: TROMBINA UMANA
Sponsors
UNIVERSITA` CAMPUS BIOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age > 18 years - patients underwent pancreatico-duodenectomy with pancreatico-jejunal anastomosis - diameter of the main pancreatic duct ≤ 3 mm - soft pancreatic parenchyma - patients without past radiation treatment on the abdomen - informed consensus Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - age 3 mm - hard pancreatic parenchyma - patients with past radiation treatment on the abdomen - absence of informed consensus - use of other biological sealant on the pancreatico-jejunal anastomosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): - amylase value in drains from 1st postoperative day in order to evaluate pancreatic fistula using ISGPF definition (2); - output of drains from 1st postoperative day;;Main Objective: investigate the role of TachoSil in the prevention of pancreatic fistula in patients underwent to PD, with a soft pancreatic parenchima and a diameter of main pancreatic duct ≤ 3 mm;Secondary Objective: analysed, in patients with or without the application of TachoSil on pancreatic anastomosis, drain fluid parameters (levels of amylase and output), rate of fistula-related complications and post-operative stay | — |
Countries
Italy
Outcome results
None listed