Status:
UNKNOWN
Effect of Thrombin-containing Collagen-based Hemostatic Matrix
Lead Sponsor:
Asan Medical Center
Conditions:
Pancreatic Tumor
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
Under the hypothesis that collagen-based hemostatic agents improve the suppression of leakage of hemostatic pancreatic fluid at the surgical site during surgery, thrombin-containing collagen-based hem...
Detailed Description
1. Synopsis * Title: Randomized controlled Study to evaluate the Effect of Thrombin-containing Collagen-based Hemostatic Matrix on Prevention of Pancreatic fistula after Pancreatectomy * Study ...
Eligibility Criteria
Inclusion
- Age: 20-80 years at the day of enrollment
- Performance: ECOG 0-2
- Patients who was scheduled for pancreatectomy due to benign or malignant tumor
- No distant metastasis
- Bone marrow function: WBC at least 3,000 / mm3, Platelet count at least 100,000 / 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.
- Patients who consented to and signed the consent
Exclusion
- Those with active or uncontrolled infections
- Those with severe psychiatric / neurological disorders
- Alcohol or other drug addicts
- Patients included in other clinical studies that may affect this study
- Patients who cannot follow the directions of the researcher
- Those with uncontrolled heart disease
- Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (cirrhosis, chronic kidney failure, heart failure, etc.)
- Pelvic tumor, benign tumor, malignant tumor in other organs
- pregnant or planning on becoming pregnant during the follow-up period
- undergoing lymphatic or coagulation disease
- known sensitivity or allergy to bovine and/or porcine substance(s)
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04357483
Start Date
February 1 2018
End Date
September 30 2020
Last Update
April 28 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan medical center
Seoul, South Korea, 05505