P00 Trial Details

A prospective, open, randomized, academic phase II, two-arm trial evaluating the effect of fibrin-coated collagen (TachoSil®) on postoperative pancreatic leakage and fistula formation from the pancreato-jejunostomy

Start:
09/2013

Contact ABCSG-Trial office

E-mail: info@abcsg.at
Phone: +43 1 408 92 30
Fax: +43 1 409 09 90

Design

Trial-P00

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Primary objectives:

  • To demonstrate that fibrin-coated collagen patch (TachoSil®) significantly decreases postoperative pancreatic leakage and prevents pancreatic fistula formation in patients undergoing partial pancreatoduodenectomy with pancreato-enteric anastomosis

Secondary objectives:

To demonstrate superior efficacy of fibrin-coated collagen patch (TachoSil®) in patients undergoing partial pancreato-duodenectomy, measured by

  • any condition / complication in association with pancreatic fistula formation according to the clinical severity grading classification of pancreatic fistula (Grades A – C)
  • the daily amount of fluid from the drainage and its content of amylase and lipase at predefined timepoints
  • the time (days) until drain removal and until fistula closure
  • surgery associated and any other perioperative complications

Inclusion criteria:

  1. Patients undergoing partial pancreato-duodenectomy with pancreato-jejunostomy
  2. Age ≥ 18
  3. Ability to comply with the protocol and attend follow up
  4. Signed written informed consent

Exclusion criteria:

  1. Known allergies against any product compound
  2. Ongoing treatment with somatostatin or octreotid
  3. Pregnant and lactating females
  4. Haemolytic anaemia
  5. Immune deficiency disease