EUCTR2013-000639-29-AT
Active, not recruiting
Phase 1
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
ABCSG (Austrian Breast & Colorectal Cancer Study Group)0 sitesFebruary 26, 2013
Conditionspancreatic surgery - evaluation of the effect of fibrin-coated collagenMedDRA version: 18.0Level: PTClassification code 10049192Term: Pancreatic fistulaSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 18.0Level: LLTClassification code 10050457Term: Pancreatic anastomotic leakSystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
DrugsTachoSil
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- pancreatic surgery - evaluation of the effect of fibrin-coated collagen
- Sponsor
- ABCSG (Austrian Breast & Colorectal Cancer Study Group)
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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