Sealing pancreato-enteric anastomosis with TachoSil

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-enteric anastomosis in patients undergoing partial pancreaticoduodenectomy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000639-29-AT

Enrollment

Unknown

Registered

2013-02-26

Start date

2013-03-27

Completion date

Unknown

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic surgery - evaluation of the effect of fibrin-coated collagen MedDRA version: 18.0 Level: PT Classification code 10049192 Term: Pancreatic fistula System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0 Level: LLT Classification code 10050457 Term: Pancreatic anastomotic leak System Organ Class: 100000004863

Interventions

Trade Name: TachoSil Product Name: TachoSil Pharmaceutical Form: Medicated sponge INN or Proposed INN: - CAS Number: 9001-32-5 Other descriptive name: HUMAN FIBRINOGEN Concentration unit: mg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • patients undergoing partial pancreatico-duodenectomy with pancreatico-jejunostomy • age = 18 • ability to comply with the protocol and attend follow up • signed written informed consent 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 62

Exclusion criteria

Exclusion criteria: • known allergies against any product compound • ongoing treatment with somatostatin or octreotid • pregnant and lactating females • haemolytic anaemia • immune deficiency disease • patients who are not eligible for general anaesthesia and operations • concurrent participation in another clinical trial with the same primary endpoint is not permitted

Design outcomes

Primary

Measure	Time frame
Main Objective: to demonstrate that fibrin-coated collagen patch (TachoSil) significantly decreases postoperative pancreatic leakage and prevents pancreatic fistula formation in patients undergoing partial pancreatico-duodenectomy with pancreato-enteric anastomosis;Secondary Objective: 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 • the time (days) until drain removal and until fistula closure • surgery associated and any other perioperative complications;Primary end point(s): evidence of pancreatic leakage or fistula according to ISGPF definition;Timepoint(s) of evaluation of this end point: evaluation after the third postoperative day	—

Measure

Time frame

Main Objective: to demonstrate that fibrin-coated collagen patch (TachoSil) significantly decreases postoperative pancreatic leakage and prevents pancreatic fistula formation in patients undergoing partial pancreatico-duodenectomy with pancreato-enteric anastomosis;Secondary Objective: 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 • the time (days) until drain removal and until fistula closure • surgery associated and any other perioperative complications;Primary end point(s): evidence of pancreatic leakage or fistula according to ISGPF definition;Timepoint(s) of evaluation of this end point: evaluation after the third postoperative day

—

Secondary

Measure	Time frame
Secondary end point(s): • any conditions/complications 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, its content of amylase and lipase, • the time (days) until drain removal and until fistula closure; the entire drain fluid volume will be measured over day of drainage and compared between groups. • Surgery associated and any other perioperative complications according to a validated classification described by Clavien and Dindo et al ;Timepoint(s) of evaluation of this end point: from surgery until fistula closure	—

Measure

Time frame

Secondary end point(s): • any conditions/complications 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, its content of amylase and lipase, • the time (days) until drain removal and until fistula closure; the entire drain fluid volume will be measured over day of drainage and compared between groups. • Surgery associated and any other perioperative complications according to a validated classification described by Clavien and Dindo et al ;Timepoint(s) of evaluation of this end point: from surgery until fistula closure

—

Countries

Austria

Contacts

Public ContactTrial Office

ABCSG (Austrian Breast & Colorectal Cancer Study Group)

info@abcsg.at+4314089230

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026