A novel surgical technique for preventing pancreatic leakage after attaching the pancreas to the small intestine
- Conditions
- Periampullary tumorsCancerMalignant neoplasm of pancreas
- Registration Number
- ISRCTN59731654
- Lead Sponsor
- Shenjing Hospital of China Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 390
1. Periampullary tumors indicated by at least two imaging examinations or pathological biopsy before surgery
2. =18 years of age
3. Provision of written informed consent by patients or their legal guardians
1. Extensive tumor metastasis
2. Abnormal blood coagulation
3. Renal dysfunction (creatinine >250 µmol/L)
4. Chronic liver disease
5. History of radiation therapy
6. American Society of Anesthesiologists (ASA) class IV-V
7. Life expectancy <48 hours
8. Lactating or pregnant women
9. Participation in other drug clinical trials
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of pancreatic fistula within 30 days after surgery (defined as an abdominal drain or incision output of fluid with an amylase level > 3 times the upper limit of institutional normal serum amylase activity for 3 days)
- Secondary Outcome Measures
Name Time Method