Status:
UNKNOWN
The Effect of Application of TachoSil® in Pancreatoduodenectomy
Lead Sponsor:
Asan Medical Center
Conditions:
Pancreatic Neoplasm
Pancreatic Periampullary Cancer
Eligibility:
All Genders
19-80 years
Phase:
PHASE4
Brief Summary
Fibrinogen/thrombin-coated collagen patch (TachoSil®) is known to have the effect of strengthening tissue anastomosis and promoting suturing to prevent leakage. The purpose of this study is to compare...
Eligibility Criteria
Inclusion
- ECOG performance score of 0-2
- Periampulary cancer or borderline tumor that is able to resection on preoperative examination
- Patients without distance metastasis
- Bone marrow function: WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
- Liver function: AST/ALT less than 3 times upper limit of normal
- Kidney function: Creatinine no greater than 1.5 times upper limit of normal
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients with distant metastases are not eligible
- Recurred periampulary cancer
- Pregnant and breastfeeding women
- Patients with active or uncontrolled infection
- Patients with uncontrolled heart disease
- Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (Liver cirrhosis, chronic kidney failure, heart failure, etc.)
- Patients who underwent other major abdominal organs surgery except for scheduled pancreatoduodenectomy (gastrectomy, colonic resection, etc.)
Key Trial Info
Start Date :
February 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT03269955
Start Date
February 27 2017
End Date
May 1 2018
Last Update
September 1 2017
Active Locations (1)
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1
Asan Medical Center
Seoul, Songpagu, South Korea, 05505