RANDOMISED PROSPECTIVE TRIAL: PREVENTION OF PANCREATIC FISTULA AFTER PANCREATICO-DUODENECTOMY USING BIOLOGICAL SEALANT - Tachosil

Conditions: - patients underwent pancreatico-duodenectomy with pancreatico-jejunal anastomosis
MedDRA version: 9.1Level: SOCClassification code 10042613

Registration Number: EUCTR2009-012994-37-IT

Lead Sponsor: IVERSITA` CAMPUS BIOMEDICO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

- age < 18 years
- patients underwent pancreatico-duodenectomy without pancreatico-jejunal anastomosis
- diameter of the main pancreatic duct > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): -amylase value in drains from 1st postoperative day in order to evaluate pancreatic fistula using ISGPF definition (2);<br>-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 &#8804; 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

Secondary Outcome Measures