Evaluation of the efficacy and safety of Hemopatch vs Fibrin sealant or patch vs no treatment on pancreatic fistula who underwent PPPD or distal pancreatectomy
Not Applicable
Completed
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Patients planning to undergo pylor-preserving pancreaticoduodenectomy or distal regional pancreatectomy due to benign or malignant pancreatic tumor
- Patients with an ASA grade 1-2 score when selecting study subjects
- Patients who consented and signed the informed consent form
Exclusion Criteria
- Patients who do not sign informed consent
- Patients who are expected to reconstruct the arteries around the surgical site
- Patients who received chemotherapy or radiation therapy before surgery
- immunosuppressed patients
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CRS-PF (Clinical Risk Score to Predict Pancreatic Fistula) : Pancreas Gland texture (Soft 1 , Firm 0) , Pathology (PDAC 1, Benign neoplasm 2, pancreatitis 3 ),pancreatic duct diameter (mm), estimated blood loss during surgery (mL) POPF (Postoperative pancreatic fistula)( biochemical leak: 0, grade B: 1, grade C: 2): serum amylase (U/L) 3 days post-surgery, humoral amylase (U/L) 3 days post-surgery, complications within 1 month after surgery : Bleeding, abscess, delayed gastric emptying, readmission within 1 month, reoperation within 1 month, percutaneous/endoscopic intervention within 1 month after surgery, surgery-related death within 3 months
- Secondary Outcome Measures
Name Time Method Gender, age, type of bile drainage before surgery, ASA grade 1.2.3, body mass index, name of operation (pylorus-preserving pancreaticoduodenectomy 1, Whipple operation 2, distal pancreatectomy 3), operation time (min)